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REVOLUTION (WFCC-133) - Treatment of Paroxysmal Atrial Fibrillation (REVOLUTION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01353586
First received: May 12, 2011
Last updated: December 22, 2015
Last verified: December 2015
Results First Received: September 20, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Paroxysmal Atrial Fibrillation
Intervention: Device: nMARQ™ System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 186 eligible subjects enrolled in this study across 8 sites in Europe. The first was enrolled on March 14, 2011 and was treated on March 15, 2011. The last was enrolled on October 16, 2012. The study’s last 12 month follow-up visit occurred on September 27, 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Main Study consisted only of subjects treated with nMARQ ablation system, without a control arm. Later, a Subpopulation Neurological Assessment (SNA) was added to evaluate for potential cerebral micro-emboli and neurological deficits post ablation. The SNA included a comparator control arm of subjects treated with the Navistar® ThermoCool®.

Reporting Groups
  Description
nMARQ™ (Main Study- Single Arm) This group of subjects underwent electrophysiological mapping and radiofrequency ablation with the Biosense Webster nMARQ™ system. The Main Study (167 subjects) consists only of subjects treated with the nMARQ catheter.
NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)

Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.

These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.

Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group.


Participant Flow:   Overall Study
    nMARQ™ (Main Study- Single Arm)     NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)  
STARTED     167     19  
Participated in Workflow Phase     20     0  
Participated in Roll-in Phase     22     0  
Participated in SNA Substudy     19     19  
COMPLETED     160     17  
NOT COMPLETED     7     2  
Procedure terminated prior to ablation                 3                 0  
Never had insertion of study catheter                 4                 1  
Neurological exam not done                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population (cohort): For the main study, this population includes enrolled subjects who underwent insertion of study catheters. For the NAVISTAR® THERMOCOOL® arm, this population includes enrolled subjects, but excludes two subjects (1 with low pre-ablation international normalized ratio (INR) and 1 missing post procedure neurological exam).

Reporting Groups
  Description
nMARQ™ (Main Study- Single Arm) This group of subjects underwent electrophysiological mapping and radiofrequency ablation with the Biosense Webster nMARQ™ system. The Main Study (167 subjects) consists only of subjects treated with the nMARQ catheter.
NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)

Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.

These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.

Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group.

Total Total of all reporting groups

Baseline Measures
    nMARQ™ (Main Study- Single Arm)     NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)     Total  
Number of Participants  
[units: participants]
  163     17     180  
Age  
[units: years]
Mean (Standard Deviation)
  58.7  (10.24)     56.5  (9.86)     58.49  (10.0)  
Gender  
[units: participants]
     
Female     51     3     54  
Male     112     14     126  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     110     14     124  
Unknown or Not Reported     53     3     56  
Race (NIH/OMB) [1]
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     110     14     124  
More than one race     0     0     0  
Unknown or Not Reported     53     3     56  
[1] Fifty-three subjects in nMARQ arm and 3 subjects in SNA Control Group didn't report ethnicity and race data because of French privacy law restrictions. These subjects are reported in Race category, "Unknown or Not Reported".



  Outcome Measures
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1.  Primary:   The Incidence of Early Onset Primary Adverse Events   [ Time Frame: Any of above events occurring within 7 days post-procedure (also including the incidence of pulmonary vein stenosis and atrio-esophageal fistula occurring > 7 days and up to one year post-procedure) ]

2.  Primary:   Incidence of Freedom From Documented Symptomatic Atrial Fibrillation   [ Time Frame: Evaluated from Day 91 to Day 240 ]

3.  Secondary:   Incidence of Non-Primary Serious Adverse Events (SAEs) up to 12 Months   [ Time Frame: 12 months post study procedure ]

4.  Secondary:   Assessment of Pulmonary Vein (PV) Narrowing and Stenosis at 3 Months After Index Ablation   [ Time Frame: Three months after index ablation ]

5.  Secondary:   Incidence of Completion of Ablation Procedure   [ Time Frame: From 7 days to 12 months post study procedure ]

6.  Secondary:   Absence of Documented Symptomatic PAF Through 6 Months and 12 Months Post Procedure   [ Time Frame: 6 and12 months post study procedure ]

7.  Secondary:   Subpopulation Neurological Assessments (SNA) Endpoint 1 - Incidence of Cerebral Embolic (ACE) Lesions Post Ablation   [ Time Frame: 48 hours post-ablation ]

8.  Secondary:   Subpopulation Neurological Assessments (SNA) Endpoint 2 - Incidence of New Neurological Findings Post Ablation   [ Time Frame: 48 hours post-ablation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Kendra McInnis, Manager, Clinical Operations
Organization: Biosense Webster, Inc
phone: 909-839-7284
e-mail: kmcinnis@its.jnj.com



Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01353586     History of Changes
Other Study ID Numbers: WFCC-133
Study First Received: May 12, 2011
Results First Received: September 20, 2015
Last Updated: December 22, 2015
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)