At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 186 enrolled
Drug / intervention
nMARQ™ Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
REVOLUTION (WFCC-133): Clinical Workflow Study for the Evaluation of the Multi-Electrode Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
In Brief
A Phase 2 clinical trial evaluating nMARQ™ System for Paroxysmal Atrial Fibrillation. Completed, enrolled 186 participants across 8 sites in 6 countries.
Detailed Summary
The purpose of this study is to assess the safety and effectiveness of the Circular and Crescent Mapping and Ablation catheters and the workflow of the Multi-Electrode Irrigated Pulmonary Vein Isolation System when used for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (PAF).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Atrial Fibrillation
CountriesBelgium, Czechia, Denmark, France, Germany, Italy
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2011
First PostedMay 2011
Primary CompletionSep 2013
TodayJul 2026
First PostedMay 13, 2011
Enrollment StartMar 1, 2011
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 15.1 years ago
Interventions
nMARQ™ Systemdevice
The nMARQ™ System is indicated for catheter-based electrophysiological mapping for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillatioon.