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

NCT01353586 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2017-06-06

Study results available
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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).

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DEVICE

nMARQ™ System

The nMARQ™ System is indicated for catheter-based electrophysiological mapping for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillatioon.

Sponsors & Collaborators

  • Biosense Webster, Inc.

    lead INDUSTRY

Principal Investigators

  • Prof. Pierre Jais, MD · Hop. Haut-Lévêque

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-01
Primary Completion
2013-09-01
Completion
2013-09-01
FDA Device
Yes

Countries

  • Belgium
  • Czechia
  • Denmark
  • France
  • Germany
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01353586 on ClinicalTrials.gov