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Atrial Fibrillation Progression Trial (ATTEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01570361
Recruitment Status : Terminated (The sponsor decided to terminate the study early due to enrolment not proceeding in accordance with expectations, independently from the study outcome.)
First Posted : April 4, 2012
Results First Posted : May 14, 2020
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Atrial Fibrillation
Interventions Device: Catheter Ablation
Drug: Drug Treatment
Enrollment 255
Recruitment Details The first subject was enrolled on 13-Feb-2012. On 27-Feb-2018, study was terminated early due to enrollment not proceeding in accordance with expectations, independently from the study outcome. The last subject completed the last visit on 29-May-2018.
Pre-assignment Details Before randomization and signing inform consent forms, all subjects were screened according protocol defined inclusion and exclusion criteria. Screening failures were excluded from the study and were not randomized.
Arm/Group Title Radiofrequency (RF) Ablation Treatment Antiarrhythmic Drug (AAD) Therapy
Hide Arm/Group Description Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™). Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
Period Title: Overall Study
Started 128 127
Received Study Treatment 102 123
Cross-over (AAD Therapy to RF Ablation) 0 15
AAD Therapy Only 0 108
Completed 46 52
Not Completed 82 75
Reason Not Completed
Subject discontinued             1             2
Sponsor closing the study             51             50
Subject excluded             5             3
Subject withdrew consent             14             9
Adverse Event             2             1
Lost to Follow-up             4             4
Death             5             4
Other             0             2
Arm/Group Title Radiofrequency (RF) Ablation Treatment Antiarrhythmic Drug (AAD) Therapy Total
Hide Arm/Group Description Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™). Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment). Total of all reporting groups
Overall Number of Baseline Participants 128 127 255
Hide Baseline Analysis Population Description
The intent-to-treat population included all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 128 participants 127 participants 255 participants
67.8  (4.83) 67.6  (4.64) 67.7  (4.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 127 participants 255 participants
Female
74
  57.8%
74
  58.3%
148
  58.0%
Male
54
  42.2%
53
  41.7%
107
  42.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years
Hide Description Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.
Arm/Group Title Radiofrequency (RF) Ablation Treatment Antiarrhythmic Drug (AAD) Therapy
Hide Arm/Group Description:
Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).
Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
Overall Number of Participants Analyzed 128 127
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Due to insufficient number of participants with events, median time and 95% CI could not be estimated using Kaplan-Meier method.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Radiofrequency (RF) Ablation Treatment, Antiarrhythmic Drug (AAD) Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments Prior to the final analysis, study had two interim analyses. Hence alpha level is 0.0231 for primary analysis adjusted for the two interim analyses.
Method Log Rank
Comments One-sided test
2.Secondary Outcome
Title Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year
Hide Description Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.
Arm/Group Title Radiofrequency (RF) Ablation Treatment Antiarrhythmic Drug (AAD) Therapy
Hide Arm/Group Description:
Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).
Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
Overall Number of Participants Analyzed 128 127
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Due to insufficient number of participants with events, median time and 95% CI could not be estimated using Kaplan-Meier method.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Radiofrequency (RF) Ablation Treatment, Antiarrhythmic Drug (AAD) Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0118
Comments The alpha level is 0.025 for this secondary endpoint.
Method Log Rank
Comments One-sided test
3.Secondary Outcome
Title Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years
Hide Description Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.
Arm/Group Title Radiofrequency (RF) Ablation Treatment Antiarrhythmic Drug (AAD) Therapy
Hide Arm/Group Description:
Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).
Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
Overall Number of Participants Analyzed 128 127
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Due to insufficient number of participants with events, median time and 95% CI could not be estimated using Kaplan-Meier method.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Radiofrequency (RF) Ablation Treatment, Antiarrhythmic Drug (AAD) Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0041
Comments The alpha level is 0.025 for this secondary endpoint.
Method Log Rank
Comments One-sided test
4.Secondary Outcome
Title Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year
Hide Description Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 1 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.
Arm/Group Title Radiofrequency (RF) Ablation Treatment Antiarrhythmic Drug (AAD) Therapy
Hide Arm/Group Description:
Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).
Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
Overall Number of Participants Analyzed 128 127
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
1.3
(0.2 to 8.6)
6.5
(3.2 to 13.2)
5.Secondary Outcome
Title Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years
Hide Description Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 2 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.
Arm/Group Title Radiofrequency (RF) Ablation Treatment Antiarrhythmic Drug (AAD) Therapy
Hide Arm/Group Description:
Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).
Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
Overall Number of Participants Analyzed 128 127
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
2.4
(0.6 to 9.4)
12.4
(7.2 to 21.0)
6.Secondary Outcome
Title Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Year
Hide Description Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Time Frame 3 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.
Arm/Group Title Radiofrequency (RF) Ablation Treatment Antiarrhythmic Drug (AAD) Therapy
Hide Arm/Group Description:
Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).
Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
Overall Number of Participants Analyzed 128 127
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
2.4
(0.6 to 9.4)
17.5
(10.7 to 27.8)
7.Secondary Outcome
Title Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years by Number of Repeat Ablations
Hide Description Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 year by number of repeat ablations were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. Endpoint applicable only to subjects randomized into the test group.
Arm/Group Title Radiofrequency (RF) Ablation Treatment
Hide Arm/Group Description:
Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).
Overall Number of Participants Analyzed 128
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Number of ablations = 0 Number Analyzed 25 participants
0.0 [1] 
(NA to NA)
Number of ablations = 1 Number Analyzed 89 participants
1.5
(0.2 to 10.4)
2 or more ablations Number Analyzed 14 participants
7.7
(1.1 to 43.4)
[1]
Due to insufficient number of participants with events, 95% CI could not be estimated using Kaplan-Meier method.
8.Secondary Outcome
Title Number of Repeat Ablations
Hide Description Number of repeat ablations refers to the total number of ablation procedures (including initial ablation procedure). If the number of repeat ablations =1 then subject only had one ablation procedure (initial ablation procedure in test group as randomized or cross-over procedure in cross-over subjects). If the number of repeat ablations is >= 2, then subject had at least one repeat procedure.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the Intent to treat population (ITT) who were randomized to RF ablation or who received any RF ablations as Cross-Over Patients randomized to AAD group. ITT population includes all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.
Arm/Group Title Radiofrequency (RF) Ablation Treatment Radiofrequency (RF) Ablation 2nd Treatment
Hide Arm/Group Description:
Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).
Participants who were initially treated with AAD therapy (1st treatment) and then crossed over to RF ablation (2nd treatment) were evaluated. AAD therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with current atrial fibrillation management guidelines.
Overall Number of Participants Analyzed 128 15
Mean (Standard Deviation)
Unit of Measure: Event of ablation
0.9  (0.57) 1.1  (0.26)
9.Secondary Outcome
Title Number of New Antiarrhythmic Drugs
Hide Description Number of new antiarrhythmic drugs were administered as per investigator's discretion and 2006 AF management guidelines.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.
Arm/Group Title Radiofrequency (RF) Ablation Treatment Antiarrhythmic Drug (AAD) Therapy
Hide Arm/Group Description:
Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).
Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
Overall Number of Participants Analyzed 128 127
Mean (Standard Deviation)
Unit of Measure: AAD drug
0.8  (1.05) 1.0  (1.23)
10.Secondary Outcome
Title Number of Participants in Sinus Rhythm at Each Visit Throughout the Follow-up
Hide Description Subject in sinus rhythm: no other rhythms documented at specific visit, based on ECG, Holter and event recorder. Percentages are calculated with respect to number of subjects with data available at corresponding visit
Time Frame 3 months, 6 months, 1 year, 2 years, 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. The number of participants analyzed at each visit is the number of participants with available data at the visit.
Arm/Group Title Radiofrequency (RF) Ablation Treatment Antiarrhythmic Drug (AAD) Therapy
Hide Arm/Group Description:
Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).
Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
Overall Number of Participants Analyzed 128 127
Measure Type: Number
Unit of Measure: Participants
3 month follow up Number Analyzed 69 participants 80 participants
51 55
6 month follow up Number Analyzed 62 participants 60 participants
49 42
1 year follow up Number Analyzed 54 participants 53 participants
41 35
2 year follow up Number Analyzed 44 participants 44 participants
37 30
3 year follow up Number Analyzed 27 participants 35 participants
20 23
11.Secondary Outcome
Title Number of Participants With Recurrent AF/AT at Each Visit Throughout the Follow-up
Hide Description Subjects with recurrent AF/AT: any AF/AT documented between previous visit up to visit analyzed at any TTM, Holter or ECG. Percentages are calculated with respect to number of subjects with data available at corresponding visit
Time Frame 3 months, 6 months, 1 year, 2 year and 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. The number of participants analyzed at each visit is the number of participants with available data at the visit.
Arm/Group Title Radiofrequency (RF) Ablation Treatment Antiarrhythmic Drug (AAD) Therapy
Hide Arm/Group Description:
Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).
Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
Overall Number of Participants Analyzed 128 127
Measure Type: Number
Unit of Measure: Participants
3 month follow up Number Analyzed 101 participants 114 participants
17 20
6 month follow up Number Analyzed 96 participants 110 participants
17 45
1 year follow up Number Analyzed 88 participants 87 participants
20 38
2 year follow up Number Analyzed 72 participants 73 participants
16 30
3 year follow up Number Analyzed 51 participants 55 participants
10 17
Time Frame 3 years follow up
Adverse Event Reporting Description Adverse events are summarized using the Safety population, which includes all subjects who had undergone insertion of an ablation catheter, either as RF ablation group or cross-over subjects; subjects who had started an investigator prescribed AAD in the AAD Group and did not initiate ablation therapy.
 
Arm/Group Title Radiofrequency (RF) Ablation Treatment Antiarrhythmic Drug (AAD) Therapy Only Antiarrhythmic Drug (AAD) Therapy - First Treatment Radiofrequency (RF) Ablation - Second Treatment
Hide Arm/Group Description Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™). Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. This group includes only those subjects received AAD only. This group of subjects received Antiarrhythmic drug (AAD) therapy first and received RF ablation treatment later. The AEs are those occurred during the AAD treatment period. This group of subjects received Antiarrhythmic drug (AAD) therapy first and received RF ablation treatment later. The AEs are those occurred during the RF treatment period.
All-Cause Mortality
Radiofrequency (RF) Ablation Treatment Antiarrhythmic Drug (AAD) Therapy Only Antiarrhythmic Drug (AAD) Therapy - First Treatment Radiofrequency (RF) Ablation - Second Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/102 (4.90%)      4/108 (3.70%)      0/15 (0.00%)      0/15 (0.00%)    
Hide Serious Adverse Events
Radiofrequency (RF) Ablation Treatment Antiarrhythmic Drug (AAD) Therapy Only Antiarrhythmic Drug (AAD) Therapy - First Treatment Radiofrequency (RF) Ablation - Second Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/102 (37.25%)      30/108 (27.78%)      7/15 (46.67%)      4/15 (26.67%)    
Blood and lymphatic system disorders         
Anaemia  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Cardiac disorders         
Acute coronary syndrome  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Angina unstable  1  0/102 (0.00%)  0 0/108 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0
Arrhythmia  1  1/102 (0.98%)  2 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Atrial fibrillation  1  8/102 (7.84%)  13 7/108 (6.48%)  9 4/15 (26.67%)  4 3/15 (20.00%)  4
Atrial flutter  1  4/102 (3.92%)  4 2/108 (1.85%)  2 0/15 (0.00%)  0 0/15 (0.00%)  0
Atrial tachycardia  1  1/102 (0.98%)  2 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Bradycardia  1  4/102 (3.92%)  5 2/108 (1.85%)  2 0/15 (0.00%)  0 0/15 (0.00%)  0
Cardiac arrest  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Cardiac failure congestive  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Cardiac tamponade  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Coronary artery stenosis  1  1/102 (0.98%)  1 1/108 (0.93%)  1 1/15 (6.67%)  1 0/15 (0.00%)  0
Intracardiac thrombus  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Myocardial infarction  1  1/102 (0.98%)  1 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Palpitations  1  1/102 (0.98%)  1 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Pericardial effusion  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Pericarditis  1  2/102 (1.96%)  2 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Sinus bradycardia  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Sinus node dysfunction  1  1/102 (0.98%)  1 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Tachyarrhythmia  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Tachycardia  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Ventricular tachyarrhythmia  1  2/102 (1.96%)  2 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Eye disorders         
Eyelid oedema  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Gastrointestinal disorders         
Chronic gastritis  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Constipation  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Diarrhoea  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Faeces discoloured  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Haematemesis  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Ileus  1  0/102 (0.00%)  0 0/108 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1
Inguinal hernia  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Melaena  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Pancreatic pseudocyst  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Proctalgia  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
General disorders         
Chest pain  1  3/102 (2.94%)  3 2/108 (1.85%)  2 0/15 (0.00%)  0 0/15 (0.00%)  0
Inflammation  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Hepatobiliary disorders         
Bile duct stenosis  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Cholangitis  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Cholecystitis  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Cholecystitis acute  1  0/102 (0.00%)  0 2/108 (1.85%)  2 0/15 (0.00%)  0 0/15 (0.00%)  0
Cholelithiasis  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Infections and infestations         
Perineal abscess  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Pneumonia  1  1/102 (0.98%)  1 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Prostate infection  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Pyelonephritis  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Injury, poisoning and procedural complications         
Acetabulum fracture  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Road traffic accident  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Subarachnoid haemorrhage  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Upper limb fracture  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Vascular pseudoaneurysm  1  1/102 (0.98%)  3 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Investigations         
Arteriogram coronary  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Back pain  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Haemarthrosis  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Osteoarthritis  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Benign neoplasm of bladder  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Bronchial carcinoma  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Lung neoplasm malignant  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Malignant melanoma  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Neoplasm malignant  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Pancreatic carcinoma  1  1/102 (0.98%)  2 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Prostate cancer  1  1/102 (0.98%)  1 1/108 (0.93%)  2 0/15 (0.00%)  0 0/15 (0.00%)  0
Prostate cancer recurrent  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Uterine cancer  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Nervous system disorders         
Cerebrovascular accident  1  1/102 (0.98%)  1 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Dizziness postural  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Nerve degeneration  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Radicular syndrome  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Syncope  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Product Issues         
Device lead damage  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Device occlusion  1  1/102 (0.98%)  3 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Psychiatric disorders         
Major depression  1  1/102 (0.98%)  2 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Renal and urinary disorders         
Urinary retention  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Reproductive system and breast disorders         
Pelvic prolapse  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Asthma  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Dyspnoea  1  0/102 (0.00%)  0 1/108 (0.93%)  1 1/15 (6.67%)  1 0/15 (0.00%)  0
Epistaxis  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Lung disorder  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Pulmonary oedema  1  2/102 (1.96%)  2 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Respiratory failure  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Sleep apnoea syndrome  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Surgical and medical procedures         
Abscess drainage  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Cardiac ablation  1  0/102 (0.00%)  0 0/108 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1
Hernia repair  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Vascular disorders         
Arteriovenous fistula  1  1/102 (0.98%)  1 1/108 (0.93%)  3 0/15 (0.00%)  0 0/15 (0.00%)  0
Haematoma  1  2/102 (1.96%)  2 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Haemorrhage  1  2/102 (1.96%)  2 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Hypertension  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Hypertensive emergency  1  1/102 (0.98%)  1 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Thrombosis  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
1
Term from vocabulary, MedDRA v19.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Radiofrequency (RF) Ablation Treatment Antiarrhythmic Drug (AAD) Therapy Only Antiarrhythmic Drug (AAD) Therapy - First Treatment Radiofrequency (RF) Ablation - Second Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/102 (36.27%)      43/108 (39.81%)      6/15 (40.00%)      4/15 (26.67%)    
Cardiac disorders         
Angina pectoris  1  0/102 (0.00%)  0 0/108 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0
Aortic valve incompetence  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Atrial fibrillation  1  13/102 (12.75%)  14 20/108 (18.52%)  22 2/15 (13.33%)  2 1/15 (6.67%)  2
Atrial flutter  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Atrial thrombosis  1  1/102 (0.98%)  1 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Bradycardia  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Cardiac failure  1  0/102 (0.00%)  0 3/108 (2.78%)  3 0/15 (0.00%)  0 0/15 (0.00%)  0
Cardiac failure chronic  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Cardiac failure congestive  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Cardiac valve disease  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Coronary artery stenosis  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Pericardial effusion  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Supraventricular extrasystoles  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Supraventricular tachycardia  1  1/102 (0.98%)  1 0/108 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0
Tachycardia  1  2/102 (1.96%)  2 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Congenital, familial and genetic disorders         
Hypertrophic cardiomyopathy  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Ear and labyrinth disorders         
Deafness  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Vertigo  1  0/102 (0.00%)  0 1/108 (0.93%)  1 1/15 (6.67%)  1 1/15 (6.67%)  1
Endocrine disorders         
Thyroid disorder  1  2/102 (1.96%)  2 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Eye disorders         
Dry eye  1  0/102 (0.00%)  0 0/108 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0
Gastrointestinal disorders         
Abdominal discomfort  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Constipation  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Diarrhoea  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Dry mouth  1  0/102 (0.00%)  0 0/108 (0.00%)  0 2/15 (13.33%)  2 0/15 (0.00%)  0
Gastrooesophageal reflux disease  1  1/102 (0.98%)  1 1/108 (0.93%)  1 1/15 (6.67%)  1 0/15 (0.00%)  0
Large intestine polyp  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Nausea  1  1/102 (0.98%)  1 1/108 (0.93%)  1 0/15 (0.00%)  0 1/15 (6.67%)  1
Proctalgia  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
General disorders         
Chest pain  1  2/102 (1.96%)  2 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Fatigue  1  2/102 (1.96%)  2 2/108 (1.85%)  2 0/15 (0.00%)  0 0/15 (0.00%)  0
Non-cardiac chest pain  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Oedema peripheral  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Pyrexia  1  2/102 (1.96%)  2 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Vessel puncture site pain  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Immune system disorders         
Anaphylactic shock  1  2/102 (1.96%)  2 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Infections and infestations         
Bronchitis  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Conjunctivitis bacterial  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Influenza  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Pneumonia  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Respiratory tract infection  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Systemic infection  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Upper respiratory tract infection  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Viral upper respiratory tract infection  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Injury, poisoning and procedural complications         
Foot fracture  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Lower limb fracture  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Rib fracture  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Upper limb fracture  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Vascular pseudoaneurysm  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Investigations         
Body temperature increased  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Electrocardiogram change  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Heart rate irregular  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Prostatic specific antigen increased  1  1/102 (0.98%)  1 1/108 (0.93%)  2 0/15 (0.00%)  0 0/15 (0.00%)  0
Metabolism and nutrition disorders         
Hyperlipidaemia  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Type 2 diabetes mellitus  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Bursitis  1  0/102 (0.00%)  0 0/108 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0
Nervous system disorders         
Cerebral ischaemia  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Neuralgia  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Restless legs syndrome  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Syncope  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Psychiatric disorders         
Depression  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Renal and urinary disorders         
Dysuria  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Haematuria  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Reproductive system and breast disorders         
Prostatic disorder  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  1/102 (0.98%)  1 5/108 (4.63%)  5 0/15 (0.00%)  0 1/15 (6.67%)  1
Bronchospasm  1  0/102 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Vascular disorders         
Haematoma  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Haemorrhage  1  1/102 (0.98%)  1 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Hypertension  1  1/102 (0.98%)  1 2/108 (1.85%)  2 0/15 (0.00%)  0 0/15 (0.00%)  0
Hypertensive crisis  1  1/102 (0.98%)  1 2/108 (1.85%)  2 0/15 (0.00%)  0 0/15 (0.00%)  0
Hypertensive emergency  1  1/102 (0.98%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Hypotension  1  2/102 (1.96%)  2 1/108 (0.93%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
1
Term from vocabulary, MedDRA v19.0
Indicates events were collected by systematic assessment
As the study was terminated early without having met primary effectiveness or futility criteria, the study results should be interpreted with caution.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
There IS an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present or publish trial results after the trial is completed. Please contact Biosense Webster, Inc. for additional information.
Results Point of Contact
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Name/Title: Liesbeth Vanderlinden
Organization: Johnson & Johnson Medical N.V., Biosense Webster
Phone: +32 (0) 2 746 3446
EMail: lvanderl@its.jnj.com
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Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01570361    
Other Study ID Numbers: ATTEST
First Submitted: March 28, 2012
First Posted: April 4, 2012
Results First Submitted: December 18, 2019
Results First Posted: May 14, 2020
Last Update Posted: May 14, 2020