Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation

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: NCT01824394
Recruitment Status : Terminated (Business Decision)
First Posted : April 4, 2013
Results First Posted : December 12, 2018
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Atrial Fibrillation
Interventions Device: nMARQ Navigation Catheters
Device: NaviStar ThermoCool Catheters
Enrollment 481
Recruitment Details The first subject was enrolled on April 1, 2013. Enrollment was terminated on May 25, 2017.
Pre-assignment Details This was a prospective, multicenter, randomized, controlled, two arm single-blind design. Enrolled subjects N=481 (subjects signed informed consent) 468 does not include 13 subjects excluded prior to randomization.
Arm/Group Title nMARQ® Group ThermoCool Group Roll-in Subjects
Hide Arm/Group Description Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter. Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter. Calibration roll-in cohort
Period Title: Overall Study
Started [1] 174 169 125
Intent to Treat Population [2] 151 149 0 [3]
Safety Population [4] 151 149 104 [5]
Per-Protocol Population [6] 150 148 0 [7]
Completed [8] 55 53 51
Not Completed 119 116 74
Reason Not Completed
Early Termination             1             1             3
Withdrawn due to Study Termination             91             83             41
Lost to Follow-up             0             9             3
Death             3             2             4
Discontinued Subjects             1             1             2
Excluded Subjects(No catheter inserted)             23             20             21
[1]
Patients who signed informed consent forms
[2]
Intent-to-Treat (ITT) population include randomized patients who have the ablation catheter inserted
[3]
Calibration Roll-in patients are not included in the ITT
[4]
Safety Population includes those patients who have the ablation catheter inserted
[5]
Calibration Roll-in patients are included in the safety population
[6]
Includes ITT patients who have undergone RF ablation and are in compliance with study protocol
[7]
Calibration Roll-in patients are not included in the per protocol population
[8]
All enrolled subjects who underwent insertion of the study catheter
Arm/Group Title nMARQ® Group THERMOCOOL® Group Roll-in Subjects Total
Hide Arm/Group Description Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter. Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter. Calibration roll-in cohort Total of all reporting groups
Overall Number of Baseline Participants 174 169 125 468
Hide Baseline Analysis Population Description
Enrolled subjects N=481 (subjects signed informed consent) 468 does not include 13 subjects; 10 subjects excluded prior to randomization, 3 excluded subjects missing data.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 174 participants 169 participants 125 participants 468 participants
62.0  (10.81) 61.8  (10.40) 63.6  (9.96) 62.4  (10.41)
[1]
Measure Analysis Population Description: Only include those enrolled subjects with data available. Enrolled subjects are those who signed informed consent forms.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 174 participants 169 participants 125 participants 468 participants
Female
66
  37.9%
60
  35.5%
50
  40.0%
176
  37.6%
Male
108
  62.1%
109
  64.5%
75
  60.0%
292
  62.4%
[1]
Measure Analysis Population Description: Enrolled subjects with data available.
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 174 participants 168 participants 125 participants 467 participants
Hispanic or Latino
6
   3.4%
3
   1.8%
5
   4.0%
14
   3.0%
Not Hispanic or Latino
168
  96.6%
165
  98.2%
120
  96.0%
453
  97.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Enrolled Subjects with data available. 467 does not include 14 subjects; 1 ThermoCool group patient missing data, 9 subjects excluded prior to randomization, 4 excluded subjects missing data.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 174 participants 169 participants 125 participants 468 participants
American Indian or Alaska Native
0
   0.0%
2
   1.2%
1
   0.8%
3
   0.6%
Asian
2
   1.1%
0
   0.0%
1
   0.8%
3
   0.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   1.1%
0
   0.0%
0
   0.0%
2
   0.4%
White
169
  97.1%
165
  97.6%
121
  96.8%
455
  97.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   0.6%
2
   1.2%
2
   1.6%
5
   1.1%
[1]
Measure Analysis Population Description: Enrolled subjects with data available.
1.Primary Outcome
Title Number of Participants With Early Onset Primary Adverse Events
Hide Description The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs
Time Frame 30 days post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title nMARQ® Group ThermoCool Group Roll-in Subjects
Hide Arm/Group Description:
Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter.
Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter.
Calibration roll-in cohort
Overall Number of Participants Analyzed 151 149 104
Measure Type: Count of Participants
Unit of Measure: Participants
8
   5.3%
7
   4.7%
9
   8.7%
2.Primary Outcome
Title Incidence of Early Onset Primary Adverse Events for the Intent-to-Treat and As-Treated Population
Hide Description The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs
Time Frame 30 days post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat and As-Treated population which includes randomized patients who have the ablation catheter inserted
Arm/Group Title nMARQ® Group ThermoCool Group
Hide Arm/Group Description:
Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter.
Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter.
Overall Number of Participants Analyzed 151 149
Measure Type: Count of Participants
Unit of Measure: Participants
8
   5.3%
7
   4.7%
Time Frame 3 years post ablation procedures
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title nMARQ® Group THERMOCOOL® Group Roll-in Subjects
Hide Arm/Group Description Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter. Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter Calibration roll-in cohort
All-Cause Mortality
nMARQ® Group THERMOCOOL® Group Roll-in Subjects
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/151 (1.99%)      2/149 (1.34%)      4/104 (3.85%)    
Hide Serious Adverse Events
nMARQ® Group THERMOCOOL® Group Roll-in Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/151 (25.17%)      25/149 (16.78%)      31/104 (29.81%)    
Blood and lymphatic system disorders       
Anaemia  1  0/151 (0.00%)  0 1/149 (0.67%)  1 1/104 (0.96%)  1
Chronic lymphocytic leukaemia (in remission)  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Hyperbilirubinaemia  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Cardiac disorders       
Acute myocardial infarction  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Angina pectoris  1  0/151 (0.00%)  0 1/149 (0.67%)  1 1/104 (0.96%)  1
Arrhythmia  1  1/151 (0.66%)  1 0/149 (0.00%)  0 1/104 (0.96%)  1
Atrial fibrillation  1  1/151 (0.66%)  1 0/149 (0.00%)  0 4/104 (3.85%)  5
Atrial flutter  1  6/151 (3.97%)  11 2/149 (1.34%)  2 2/104 (1.92%)  3
Atrioventricular block  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Bradycardia  1  0/151 (0.00%)  0 0/149 (0.00%)  0 2/104 (1.92%)  2
Cardiac arrest  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Cardiogenic shock  1  0/151 (0.00%)  0 1/149 (0.67%)  1 0/104 (0.00%)  0
Chest pain  1  0/151 (0.00%)  0 2/149 (1.34%)  2 0/104 (0.00%)  0
Coronary artery disease  1  0/151 (0.00%)  0 1/149 (0.67%)  1 0/104 (0.00%)  0
Coronary artery occlusion  1  0/151 (0.00%)  0 2/149 (1.34%)  2 1/104 (0.96%)  1
Dyspnoea  1  0/151 (0.00%)  0 1/149 (0.67%)  1 4/104 (3.85%)  4
Fluid overload  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Left ventricular dysfunction  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Myocardial infarction  1  0/151 (0.00%)  0 0/149 (0.00%)  0 2/104 (1.92%)  2
Palpitations  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  2
Pericardial effusion  1  3/151 (1.99%)  3 1/149 (0.67%)  1 0/104 (0.00%)  0
Pericarditis  1  2/151 (1.32%)  2 0/149 (0.00%)  0 2/104 (1.92%)  2
Presyncope  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Pulmonary oedema  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Syncope  1  2/151 (1.32%)  2 1/149 (0.67%)  1 1/104 (0.96%)  1
Tachycardia  1  1/151 (0.66%)  1 1/149 (0.67%)  3 1/104 (0.96%)  1
Endocrine disorders       
Goitre  1  1/151 (0.66%)  2 0/149 (0.00%)  0 0/104 (0.00%)  0
Gastrointestinal disorders       
Abdominal hernia  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Abdominal pain  1  1/151 (0.66%)  1 1/149 (0.67%)  1 0/104 (0.00%)  0
Appendicitis  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Colon cancer  1  0/151 (0.00%)  0 1/149 (0.67%)  1 0/104 (0.00%)  0
Diarrhoea  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Enterocele  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Gastritis haemorrhagic  1  0/151 (0.00%)  0 1/149 (0.67%)  1 0/104 (0.00%)  0
Gastroenteritis  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Gastrointestinal haemorrhage  1  1/151 (0.66%)  1 0/149 (0.00%)  0 1/104 (0.96%)  1
Gastrooesophageal reflux disease  1  0/151 (0.00%)  0 1/149 (0.67%)  1 0/104 (0.00%)  0
Inguinal hernia  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Intestinal obstruction  1  0/151 (0.00%)  0 1/149 (0.67%)  1 0/104 (0.00%)  0
Pancreatitis acute  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Rectal cancer  1  0/151 (0.00%)  0 1/149 (0.67%)  1 0/104 (0.00%)  0
Retroperitoneal haematoma  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
General disorders       
Chest discomfort  1  0/151 (0.00%)  0 1/149 (0.67%)  1 0/104 (0.00%)  0
Device dislocation  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  2
Device related infection  1  0/151 (0.00%)  0 1/149 (0.67%)  1 0/104 (0.00%)  0
Implant site infection  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Pyrexia  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Hepatobiliary disorders       
Cholelithiasis  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Hepatic cancer metastatic  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Immune system disorders       
Asthma  1  0/151 (0.00%)  0 1/149 (0.67%)  1 0/104 (0.00%)  0
Infections and infestations       
Bronchitis  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Cystitis  1  0/151 (0.00%)  0 1/149 (0.67%)  1 0/104 (0.00%)  0
Pneumonia  1  0/151 (0.00%)  0 1/149 (0.67%)  1 2/104 (1.92%)  3
Sepsis  1  0/151 (0.00%)  0 1/149 (0.67%)  1 0/104 (0.00%)  0
Injury, poisoning and procedural complications       
Drug toxicity  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Hip fracture  1  1/151 (0.66%)  1 0/149 (0.00%)  0 2/104 (1.92%)  2
Joint dislocation  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Lumbar vertebral fracture  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Post procedural haematoma  1  0/151 (0.00%)  0 1/149 (0.67%)  1 0/104 (0.00%)  0
Postoperative fever  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Rib fracture  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Skin laceration  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Urinary retention postoperative  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Vascular pseudoaneurysm  1  2/151 (1.32%)  2 1/149 (0.67%)  1 1/104 (0.96%)  1
Investigations       
Anticoagulation drug level below therapeutic  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Blood sodium decreased  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Heart rate increased  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
International normalised ratio decreased  1  0/151 (0.00%)  0 1/149 (0.67%)  1 1/104 (0.96%)  1
International normalised ratio increased  1  0/151 (0.00%)  0 1/149 (0.67%)  1 0/104 (0.00%)  0
Metabolism and nutrition disorders       
Hyponatraemia  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Respiratory failure  1  0/151 (0.00%)  0 1/149 (0.67%)  1 0/104 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Intervertebral disc disorder  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Intervertebral disc protrusion  1  0/151 (0.00%)  0 0/149 (0.00%)  0 2/104 (1.92%)  2
Muscular weakness  1  0/151 (0.00%)  0 1/149 (0.67%)  1 0/104 (0.00%)  0
Musculoskeletal pain  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Osteoarthritis  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Brain neoplasm  1  0/151 (0.00%)  0 1/149 (0.67%)  1 0/104 (0.00%)  0
Ependymoma  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Lung neoplasm  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Tumour haemorrhage  1  0/151 (0.00%)  0 1/149 (0.67%)  1 0/104 (0.00%)  0
Lung neoplasm malignant  1  0/151 (0.00%)  0 1/149 (0.67%)  1 1/104 (0.96%)  1
Nervous system disorders       
Cerebrovascular accident  1  2/151 (1.32%)  2 1/149 (0.67%)  1 2/104 (1.92%)  2
Phrenic nerve paralysis  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Transient ischaemic attack  1  0/151 (0.00%)  0 1/149 (0.67%)  1 1/104 (0.96%)  1
Dizziness  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Gait disturbance  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Psychiatric disorders       
Mental status changes  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Renal and urinary disorders       
Haematuria  1  1/151 (0.66%)  2 0/149 (0.00%)  0 0/104 (0.00%)  0
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Cervical dysplasia  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Acute respiratory distress syndrome  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Chronic obstructive pulmonary disease  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Hypoxia  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Pleural effusion  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Pneumothorax  1  0/151 (0.00%)  0 1/149 (0.67%)  1 0/104 (0.00%)  0
Surgical and medical procedures       
Cardiac pacemaker insertion  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Explorative laparotomy  1  0/151 (0.00%)  0 1/149 (0.67%)  1 0/104 (0.00%)  0
Hip arthroplasty  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Knee arthroplasty  1  0/151 (0.00%)  0 0/149 (0.00%)  0 2/104 (1.92%)  2
Meniscus operation  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Oesophagogastric fundoplasty  1  0/151 (0.00%)  0 0/149 (0.00%)  0 1/104 (0.96%)  1
Spinal fusion surgery  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Umbilical hernia repair  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Vascular disorders       
Arteriovenous fistula  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Embolism  1  0/151 (0.00%)  0 1/149 (0.67%)  1 0/104 (0.00%)  0
Haematoma  1  1/151 (0.66%)  1 2/149 (1.34%)  2 0/104 (0.00%)  0
Haemorrhage  1  0/151 (0.00%)  0 0/149 (0.00%)  0 2/104 (1.92%)  2
Vascular pseudoaneurysm  1  0/151 (0.00%)  0 1/149 (0.67%)  1 0/104 (0.00%)  0
Vessel puncture site haemorrhage  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
Carotid artery stenosis  1  1/151 (0.66%)  1 0/149 (0.00%)  0 0/104 (0.00%)  0
1
Term from vocabulary, MedDRA version 13.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
nMARQ® Group THERMOCOOL® Group Roll-in Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   86/151 (56.95%)      86/149 (57.72%)      74/104 (71.15%)    
Blood and lymphatic system disorders       
Anaemia  1  0/151 (0.00%)  0 3/149 (2.01%)  3 2/104 (1.92%)  2
Cardiac disorders       
Atrial flutter  1  2/151 (1.32%)  6 3/149 (2.01%)  3 4/104 (3.85%)  8
Bradycardia  1  4/151 (2.65%)  4 1/149 (0.67%)  1 2/104 (1.92%)  2
Chest pain  1  1/151 (0.66%)  10 1/149 (0.67%)  11 6/104 (5.77%)  9
Dyspnoea  1  3/151 (1.99%)  3 2/149 (1.34%)  2 2/104 (1.92%)  2
Fluid overload  1  1/151 (0.66%)  1 3/149 (2.01%)  3 2/104 (1.92%)  2
Oedema peripheral  1  2/151 (1.32%)  3 2/149 (1.34%)  3 2/104 (1.92%)  2
Palpitations  1  1/151 (0.66%)  1 2/149 (1.34%)  2 2/104 (1.92%)  2
Pericardial effusion  1  6/151 (3.97%)  6 4/149 (2.68%)  4 7/104 (6.73%)  7
Presyncope  1  2/151 (1.32%)  2 2/149 (1.34%)  2 4/104 (3.85%)  4
Supraventricular tachycardia  1  0/151 (0.00%)  0 2/149 (1.34%)  2 1/104 (0.96%)  1
Syncope  1  1/151 (0.66%)  1 0/149 (0.00%)  0 2/104 (1.92%)  2
Tachycardia  1  5/151 (3.31%)  5 4/149 (2.68%)  4 5/104 (4.81%)  6
Ear and labyrinth disorders       
Tinnitus  1  0/151 (0.00%)  0 2/149 (1.34%)  2 0/104 (0.00%)  0
Endocrine disorders       
Thyroid disorder  1  0/151 (0.00%)  0 2/149 (1.34%)  2 0/104 (0.00%)  0
Eye disorders       
Cataract  1  2/151 (1.32%)  2 1/149 (0.67%)  1 0/104 (0.00%)  0
Visual impairment  1  1/151 (0.66%)  1 2/149 (1.34%)  2 1/104 (0.96%)  1
Corneal abrasionCorneal abrasion  1  1/151 (0.66%)  1 2/149 (1.34%)  2 0/104 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  1/151 (0.66%)  1 2/149 (1.34%)  2 0/104 (0.00%)  0
Diarrhoea  1  1/151 (0.66%)  1 2/149 (1.34%)  2 2/104 (1.92%)  2
Gastrooesophageal reflux disease  1  0/151 (0.00%)  0 2/149 (1.34%)  2 1/104 (0.96%)  1
Nausea  1  1/151 (0.66%)  1 3/149 (2.01%)  3 0/104 (0.00%)  0
Oesophageal injury  1  2/151 (1.32%)  2 1/149 (0.67%)  1 0/104 (0.00%)  0
General disorders       
Chest discomfort  1  0/151 (0.00%)  0 2/149 (1.34%)  3 0/104 (0.00%)  0
Fatigue  1  0/151 (0.00%)  0 2/149 (1.34%)  3 1/104 (0.96%)  1
Pyrexia  1  2/151 (1.32%)  2 4/149 (2.68%)  4 1/104 (0.96%)  1
Vessel puncture site haematoma  1  1/151 (0.66%)  1 1/149 (0.67%)  1 3/104 (2.88%)  3
Immune system disorders       
Hypersensitivity  1  5/151 (3.31%)  5 0/149 (0.00%)  0 2/104 (1.92%)  2
Infections and infestations       
Bronchitis  1  4/151 (2.65%)  4 0/149 (0.00%)  0 4/104 (3.85%)  5
Influenza  1  0/151 (0.00%)  0 2/149 (1.34%)  2 0/104 (0.00%)  0
Localised infection  1  3/151 (1.99%)  4 0/149 (0.00%)  0 1/104 (0.96%)  2
Pneumonia  1  2/151 (1.32%)  2 2/149 (1.34%)  2 1/104 (0.96%)  1
Sinusitis  1  4/151 (2.65%)  4 1/149 (0.67%)  1 4/104 (3.85%)  4
Urinary tract infection  1  1/151 (0.66%)  10 1/149 (0.67%)  1 4/104 (3.85%)  4
Injury, poisoning and procedural complications       
Arthropod bite  1  0/151 (0.00%)  0 2/149 (1.34%)  2 0/104 (0.00%)  0
Contusion  1  1/151 (0.66%)  1 2/149 (1.34%)  2 0/104 (0.00%)  0
Procedural complication  1  1/151 (0.66%)  1 0/149 (0.00%)  0 2/104 (1.92%)  2
Vascular pseudoaneurysm  1  0/151 (0.00%)  0 2/149 (1.34%)  2 1/104 (0.96%)  1
Investigations       
Heart rate increased  1  0/151 (0.00%)  0 3/149 (2.01%)  3 0/104 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  3/151 (1.99%)  3 2/149 (1.34%)  2 2/104 (1.92%)  2
Back pain  1  1/151 (0.66%)  1 2/149 (1.34%)  2 0/104 (0.00%)  0
Musculoskeletal pain  1  2/151 (1.32%)  2 1/149 (0.67%)  1 1/104 (0.96%)  1
Pain in extremity  1  4/151 (2.65%)  5 0/149 (0.00%)  0 1/104 (0.96%)  1
Nervous system disorders       
Dysphonia  1  1/151 (0.66%)  1 0/149 (0.00%)  0 2/104 (1.92%)  2
Headache  1  3/151 (1.99%)  4 0/149 (0.00%)  0 0/104 (0.00%)  0
Hypoaesthesia  1  0/151 (0.00%)  0 0/149 (0.00%)  0 2/104 (1.92%)  2
Sleep apnoea syndrome  1  5/151 (3.31%)  5 2/149 (1.34%)  2 4/104 (3.85%)  4
Dizziness  1  0/151 (0.00%)  0 3/149 (2.01%)  3 1/104 (0.96%)  1
Renal and urinary disorders       
Haematuria  1  4/151 (2.65%)  4 2/149 (1.34%)  2 2/104 (1.92%)  2
Renal failure acute  1  1/151 (0.66%)  1 0/149 (0.00%)  0 2/104 (1.92%)  2
Urinary retention  1  2/151 (1.32%)  2 0/149 (0.00%)  0 1/104 (0.96%)  1
Respiratory, thoracic and mediastinal disorders       
Cough  1  3/151 (1.99%)  3 2/149 (1.34%)  2 1/104 (0.96%)  1
Pleural effusion  1  2/151 (1.32%)  2 1/149 (0.67%)  1 1/104 (0.96%)  1
Vascular disorders       
Haematoma  1  1/151 (0.66%)  11 7/149 (4.70%)  7 1/104 (0.96%)  1
Haemorrhage  1  1/151 (0.66%)  1 2/149 (1.34%)  2 0/104 (0.00%)  0
Hypertension  1  9/151 (5.96%)  10 8/149 (5.37%)  9 7/104 (6.73%)  8
Hypotension  1  2/151 (1.32%)  2 2/149 (1.34%)  2 1/104 (0.96%)  1
1
Term from vocabulary, MedDRA version 13.0
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.
The sponsor can review results communications prior to public release and can embargo communications regarding trial results for 60 to 180 days from the time submitted to the sponsor for review. For multicenter studies, the first results communications should be a joint multicenter publication. PIs may communicate results from their institution as indicated above if a multicenter publication is not submitted by the Sponsor or representatives within 12 months of the study's conclusion.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Megan Holden
Organization: Biosense Webster, Inc.
Phone: (949) 923-4700
EMail: mholden8@its.jnj.com
Layout table for additonal information
Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01824394    
Other Study ID Numbers: reMARQable
First Submitted: April 1, 2013
First Posted: April 4, 2013
Results First Submitted: November 26, 2018
Results First Posted: December 12, 2018
Last Update Posted: February 7, 2019