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

NCT01824394 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 481

Last updated 2025-02-04

Study results available
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Summary

To demonstrate safety and effectiveness of nMARQ Catheter System \[nMARQ\] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF).

Conditions

Interventions

DEVICE

nMARQ Navigation Catheters

DEVICE

NaviStar ThermoCool Catheters

Sponsors & Collaborators

  • Biosense Webster, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-01
Primary Completion
2017-11-26
Completion
2017-11-26
FDA Device
Yes

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Entities

Diseases

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 NCT01824394 on ClinicalTrials.gov