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Trial record 1 of 1 for:    TactiSense IDE SJM-CIP-10216
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TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation (TactiSense)

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ClinicalTrials.gov Identifier: NCT03354663
Recruitment Status : Completed
First Posted : November 28, 2017
Results First Posted : August 20, 2019
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Paroxysmal Atrial Fibrillation
Intervention Device: TactiCath SE
Enrollment 156
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TactiCath SE
Hide Arm/Group Description

Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.

TactiCath SE: Ablation to achieve pulmonary vein isolation.

Period Title: Enrollment to Catheter Insertion
Started 156
Completed 151
Not Completed 5
Reason Not Completed
Did not meet inc/exc criteria             4
Adverse Event             1
Period Title: Completed 30-day Visit
Started 151
Completed 149
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Missed Visit             1
Arm/Group Title TactiCath SE
Hide Arm/Group Description

Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.

TactiCath SE: Ablation to achieve pulmonary vein isolation.

Overall Number of Baseline Participants 151
Hide Baseline Analysis Population Description
Population includes all subjects with device inserted into vasculature.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
<=18 years
0
   0.0%
Between 18 and 65 years
75
  49.7%
>=65 years
76
  50.3%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 151 participants
65.0
(56.0 to 71.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
Female
60
  39.7%
Male
91
  60.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
Hispanic or Latino
3
   2.0%
Not Hispanic or Latino
125
  82.8%
Unknown or Not Reported
23
  15.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
American Indian or Alaska Native
1
   0.7%
Asian
2
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   0.7%
White
123
  81.5%
More than one race
3
   2.0%
Unknown or Not Reported
21
  13.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants
United States 101
Italy 12
Australia 22
Germany 21
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 151 participants
28.0  (5.0)
Coronary Artery Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
20
  13.2%
Heart Failure  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
4
   2.6%
Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
80
  53.0%
Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
15
   9.9%
Stoke/Transient Ischemic Attack  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
14
   9.3%
Myocardial Infarction  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
6
   4.0%
Obstructive Sleep Apnea  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
20
  13.2%
Structural Heart Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
5
   3.3%
Known Family History of Cardiovascular Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
81
  53.6%
Left Ventricular Ejection Fraction  
Median (Inter-Quartile Range)
Unit of measure:  %
Number Analyzed 151 participants
60.7
(55.0 to 65.0)
Left Atrium Diameter  
Median (Inter-Quartile Range)
Unit of measure:  Centimeters
Number Analyzed 151 participants
3.8
(3.3 to 4.3)
Pacemaker or Implantable Cardiac Monitor  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
19
  12.6%
1.Primary Outcome
Title Rate of Serious Adverse Events
Hide Description

The primary safety endpoint is the rate of device or procedure-related serious adverse events occurring within 7 days of the index procedure. SAEs related solely to arrhythmia recurrence (without coexisting conditions such as thromboembolism, worsening heart failure, etc.) will not be considered primary safety endpoint events. The SAEs that will be included in this endpoint are:

  • Atrial-esophageal fistula
  • AV block
  • Cardiac Perforation/ Tamponade
  • Death
  • Diaphragmatic paralysis
  • Gastroparesis
  • Hospitalization
  • Myocardial Infarction
  • Pericarditis
  • Pneumothorax
  • Pulmonary edema
  • Pulmonary vein stenosis
  • Stroke
  • Thromboembolism
  • Transient ischemic attack
  • Vascular access complications

Atrial-esophageal fistula, cardiac perforation/tamponade, and pulmonary vein stenosis that occur >7 days post procedure through 30 days will also contribute to the primary endpoint.

Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with device inserted into vasculature and either experienced a primary endpoint event or completed 30 days of follow up.
Arm/Group Title TactiCath SE - Safety Population
Hide Arm/Group Description:

Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.

TactiCath SE: Ablation to achieve pulmonary vein isolation.

Includes all subjects with catheter inserted into vasculature.

Overall Number of Participants Analyzed 149
Measure Type: Count of Participants
Unit of Measure: Participants
7
   4.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TactiCath SE - Safety Population
Comments

The hypothesis is formally expressed as:

H0: P ≥ 16.2% Ha: P < 16.2%, where P is the percentage of subjects with a primary safety endpoint event. The hypothesis will be tested based on a one-sided exact test of binomial proportions at the one-sided 0.05 alpha level.

Type of Statistical Test Other
Comments Single arm trial
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial Exact Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion
Estimated Value 0.047
Confidence Interval (1-Sided) 95%
0.0864
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Procedural Success
Hide Description The primary effectiveness endpoint is acute procedural success, where acute procedural success is defined as confirmation of entrance block in all pulmonary veins
Time Frame 0 days
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness Population - all subjects with device inserted into vasculature
Arm/Group Title TactiCath SE
Hide Arm/Group Description:

Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.

TactiCath SE: Ablation to achieve pulmonary vein isolation.

Overall Number of Participants Analyzed 151
Measure Type: Count of Participants
Unit of Measure: Participants
148
  98.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TactiCath SE
Comments [Not Specified]
Type of Statistical Test Other
Comments

The hypothesis is formally expressed as:

H0: P < 90% Ha: P ≥ 90%, where P is the percentage of subjects with acute success. The hypothesis will be tested based on a one-sided exact test of binomial proportions at the one-sided 0.05 alpha level. Rejection of the null hypothesis will indicate study success.

Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Binomial Exact Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion
Estimated Value 0.98
Confidence Interval (1-Sided) 95%
0.9495
Estimation Comments [Not Specified]
3.Other Pre-specified Outcome
Title Average Power Delivered
Hide Description This outcome is the average power delivered for a case.
Time Frame During Procedure
Hide Outcome Measure Data
Hide Analysis Population Description
The population includes only subjects with at least some radiofrequency energy delivered.
Arm/Group Title RF Population
Hide Arm/Group Description:
Group of subjects with at least some RF energy delivered
Overall Number of Participants Analyzed 150
Median (Inter-Quartile Range)
Unit of Measure: Watts
29.0
(26.0 to 32.0)
4.Other Pre-specified Outcome
Title Index Cases Achieving ≥ 90% Lesions With ≥ 10 Contact Force
Hide Description Proportion of index cases achieving ≥ 90% lesions with ≥10g contact force
Time Frame 0 days
Hide Outcome Measure Data
Hide Analysis Population Description
Population includes all subjects with at least some radiofrequency energy delivered.
Arm/Group Title RF Population
Hide Arm/Group Description:
Group of subjects with at least some RF energy delivered
Overall Number of Participants Analyzed 149
Measure Type: Count of Participants
Unit of Measure: Participants
5
   3.4%
5.Other Pre-specified Outcome
Title Number of Participants Experiencing Serious Adverse Events Within 30 Days
Hide Description Serious adverse events and adverse events related to the procedure and/or ablation catheter through 30 days post index ablation. This excludes the events identified in the primary safety endpoint.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Population includes all subjects with ablation catheter inserted.
Arm/Group Title TactiCath SE
Hide Arm/Group Description:

Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.

TactiCath SE: Ablation to achieve pulmonary vein isolation.

Overall Number of Participants Analyzed 151
Measure Type: Count of Participants
Unit of Measure: Participants
Servious AE Related to Device or Procedure
5
   3.3%
Non-Serious AE Related to Device or Procedure
23
  15.2%
6.Other Pre-specified Outcome
Title Number of Participants Experiencing a Serious Adverse Event Within 1 Year
Hide Description Serious adverse events and adverse events related to the procedure and/or ablation catheter through 1 year post index ablation
Time Frame 1 year
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title One-year Freedom From AF
Hide Description One-year freedom from AF, defined as freedom from symptomatic AF, atrial flutter (AFL), and atrial tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3-month blanking period.
Time Frame 1 year
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title One-year Drug-free Success From AF
Hide Description One-year drug-free success defined as freedom from any AF/AFL/AT lasting at least 30 seconds or any Class I or III AAD after removal from antiarrhythmic drug therapy as assessed from the end of the 3-month blanking period to 12 months following the ablation procedure.
Time Frame 1 year
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Changes in EQ-5D-5L Scores
Hide Description Changes in EQ-5D-5L scores from baseline to follow up at 3, 6, and 12 months
Time Frame 1 year
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Changes in AFEQT Scores
Hide Description Changes in AFEQT scores from baseline to follow up at 3, 6, and 12 months
Time Frame 1 year
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Health Care Utilization
Hide Description Cardiovascular-related health care utilization through 12 months post index ablation
Time Frame 1 year
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Force Time Integral (FTI) and Lesion Index (LSI)
Hide Description FTI and LSI will be derived from the available EnSite Precision data. Descriptive statistics will be generated for both variables.
Time Frame 0 days
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title Average Catheter Temperature
Hide Description This outcome is the average temperature (by lesion) for a case.
Time Frame 0 days
Hide Outcome Measure Data
Hide Analysis Population Description
The population includes only subjects with at least some radiofrequency energy delivered.
Arm/Group Title RF Population
Hide Arm/Group Description:
Group of subjects with at least some RF energy delivered
Overall Number of Participants Analyzed 149
Median (Inter-Quartile Range)
Unit of Measure: degrees celsius
33.4
(32.5 to 34.6)
14.Other Pre-specified Outcome
Title Number of Participants With Recommended Irrigation Flow Rate Used During Procedure
Hide Description This outcome is whether or not the recommended irrigation flow rate was used for a case.
Time Frame 0 days
Hide Outcome Measure Data
Hide Analysis Population Description
The population includes only subjects with at least some radiofrequency energy delivered.
Arm/Group Title RF Population
Hide Arm/Group Description:
Group of subjects with at least some RF energy delivered
Overall Number of Participants Analyzed 150
Measure Type: Count of Participants
Unit of Measure: Participants
140
  93.3%
15.Other Pre-specified Outcome
Title Contact Force During Procedure
Hide Description This outcome is the average contact force for a case.
Time Frame 0 days
Hide Outcome Measure Data
Hide Analysis Population Description
The population includes only subjects with at least some radiofrequency energy delivered.
Arm/Group Title RF Population
Hide Arm/Group Description:
Group of subjects with at least some RF energy delivered
Overall Number of Participants Analyzed 149
Mean (Standard Deviation)
Unit of Measure: grams
12.1  (4.7)
16.Other Pre-specified Outcome
Title Total Procedure Time
Hide Description This outcome is the total procedure time for a case.
Time Frame 0 days
Hide Outcome Measure Data
Hide Analysis Population Description
The population includes only subjects with at least some radiofrequency energy delivered.
Arm/Group Title RF Population
Hide Arm/Group Description:
Group of subjects with at least some RF energy delivered
Overall Number of Participants Analyzed 150
Median (Inter-Quartile Range)
Unit of Measure: minutes
159.5
(123.0 to 206.0)
17.Other Pre-specified Outcome
Title Ablation Time - First to Last Ablation
Hide Description This outcome is the total ablation time for a case. This is the time from first to last ablation.
Time Frame 0 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The population includes only subjects with at least some radiofrequency energy delivered.
Arm/Group Title RF Population
Hide Arm/Group Description:
Group of subjects with at least some RF energy delivered
Overall Number of Participants Analyzed 150
Median (Inter-Quartile Range)
Unit of Measure: minutes
84.0
(56.0 to 127.0)
18.Other Pre-specified Outcome
Title Fluoroscopy Time
Hide Description This outcome is the total fluoroscopy time for a case.
Time Frame 0 days
Hide Outcome Measure Data
Hide Analysis Population Description
The population includes only subjects with at least some radiofrequency energy delivered.
Arm/Group Title RF Population
Hide Arm/Group Description:
Group of subjects with at least some RF energy delivered
Overall Number of Participants Analyzed 150
Median (Inter-Quartile Range)
Unit of Measure: minutes
9.0
(5.0 to 16.0)
19.Other Pre-specified Outcome
Title Radiofrequency (RF) Application Time
Hide Description This outcome is the total RF application time for a case.
Time Frame 0 days
Hide Outcome Measure Data
Hide Analysis Population Description
The population includes only subjects with at least some radiofrequency energy delivered.
Arm/Group Title RF Population
Hide Arm/Group Description:
Group of subjects with at least some RF energy delivered
Overall Number of Participants Analyzed 149
Median (Inter-Quartile Range)
Unit of Measure: minutes
35.7
(28.9 to 51.9)
20.Other Pre-specified Outcome
Title Number of Participants Using AutoMark
Hide Description This outcome is the number of cases using AutoMark.
Time Frame 0 days
Hide Outcome Measure Data
Hide Analysis Population Description
The population includes only subjects with at least some radiofrequency energy delivered.
Arm/Group Title RF Population
Hide Arm/Group Description:
Group of subjects with at least some RF energy delivered
Overall Number of Participants Analyzed 150
Measure Type: Count of Participants
Unit of Measure: Participants
149
  99.3%
Time Frame 30 days
Adverse Event Reporting Description Adverse events include events that are not necessarily related to the device or procedure.
 
Arm/Group Title TactiCath SE
Hide Arm/Group Description

Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.

TactiCath SE: Ablation to achieve pulmonary vein isolation.

All-Cause Mortality
TactiCath SE
Affected / at Risk (%)
Total   0/156 (0.00%)    
Hide Serious Adverse Events
TactiCath SE
Affected / at Risk (%) # Events
Total   21/156 (13.46%)    
Blood and lymphatic system disorders   
Vascular Bleeding/Local Hematomas/Ecchymosis   1/156 (0.64%)  1
Cardiac disorders   
Arrhythmias   7/156 (4.49%)  8
Cardiac Perforation/Tamponade   2/156 (1.28%)  2
Pericardial Effusion   3/156 (1.92%)  3
Pericarditis   1/156 (0.64%)  1
Ventricular Tachyarrhythmia   1/156 (0.64%)  1
Gastrointestinal disorders   
Atrial-Esophageal Fistula *  1/156 (0.64%)  1
Infections *  1/156 (0.64%)  1
General disorders   
Syncope/Dizziness *  1/156 (0.64%)  1
Hepatobiliary disorders   
Cholecystitis *  1/156 (0.64%)  1
Infections and infestations   
Infections *  1/156 (0.64%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Gastroparesis *  1/156 (0.64%)  1
Nervous system disorders   
Cerebrovascular Accident/ Stroke   1/156 (0.64%)  1
Renal and urinary disorders   
Urinary Retention *  1/156 (0.64%)  1
Vascular disorders   
Hypertension *  1/156 (0.64%)  1
Thromboembolism   1/156 (0.64%)  1
Vascular Damage *  1/156 (0.64%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TactiCath SE
Affected / at Risk (%) # Events
Total   25/156 (16.03%)    
Cardiac disorders   
Chest Pain/Discomfort *  5/156 (3.21%)  5
Pericardial Effusion   1/156 (0.64%)  1
Pericarditis   6/156 (3.85%)  6
Syncope/Dizziness *  1/156 (0.64%)  1
Gastrointestinal disorders   
Epigastric Fullness *  1/156 (0.64%)  1
General disorders   
Low Grade Temp *  1/156 (0.64%)  1
Infections and infestations   
Infections *  3/156 (1.92%)  3
Musculoskeletal and connective tissue disorders   
Wrist Pain With Swelling And Bruising *  1/156 (0.64%)  1
Renal and urinary disorders   
Infections *  1/156 (0.64%)  1
Skin and subcutaneous tissue disorders   
Allergic Reaction *  1/156 (0.64%)  1
Vascular disorders   
Hypotension *  1/156 (0.64%)  1
Vascular Access Complication   2/156 (1.28%)  2
Vascular Bleeding/Local Hematomas/Ecchymosis   3/156 (1.92%)  3
Volume Overload *  2/156 (1.28%)  2
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Steven Madej
Organization: Abbott
Phone: 651-756-2230
EMail: steven.madej@abbott.com
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03354663    
Other Study ID Numbers: SJM-CIP-10216
First Submitted: November 17, 2017
First Posted: November 28, 2017
Results First Submitted: August 1, 2019
Results First Posted: August 20, 2019
Last Update Posted: January 28, 2020