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CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF)

NCT01984346 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2023-11-13

Study results available
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Summary

This is a multi-center, open label, randomized pivotal study evaluating the safety and efficacy of the EPi-Sense-AF Guided Coagulation System for the treatment of persistent AF patients, refractory or intolerant to at least one Class I and/or III Anti Arrhythmic Drug (AAD).

Conditions

  • Persistent Atrial Fibrillation

Interventions

DEVICE

AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax

Convergent Epicardial Endocardial Ablation Procedure

DEVICE

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering

Endocardial Catheter Ablation Procedure

Sponsors & Collaborators

  • AtriCure, Inc.

    lead INDUSTRY

Principal Investigators

  • David DeLurgio, MD · Emory St Joseph's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2019-08-31
Completion
2023-10-31

Countries

  • United States
  • United Kingdom

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 NCT01984346 on ClinicalTrials.gov