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First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Persistent Atrial Fibrillation Treatment (RAAFT-3)

NCT04037397 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-11-12

No results posted yet for this study

Summary

The purpose of this study is to determine if catheter-based atrial fibrillation (AF) ablation is superior to treatment with antiarrhythmic drugs as a first-line therapy for symptomatic persistent AF.

Conditions

Interventions

DRUG

Anti Arrhythmics

Propafenone or Flecanide or Sotalol or Dofetilide or Dronedarone or Amiodarone. The subject must first fail a Class 1C or III drug prior to starting Amiodarone

PROCEDURE

Pulmonary Vein Isolation performed by Radio Frequency Catheter Ablation

Approved Biosense Webster Inc. catheter devices should be used to perform RFCA. Ablation will be done to achieve entrance block into all pulmonary veins

Sponsors & Collaborators

  • Biosense Webster, Inc.

    collaborator INDUSTRY

  • Texas Cardiac Arrhythmia Research Foundation

    collaborator OTHER

  • University of Pennsylvania

    lead OTHER

Principal Investigators

  • Andrea Natale, MD · Texas Cardiac Arrhythmia Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-24
Primary Completion
2024-10-01
Completion
2024-10-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT04037397 on ClinicalTrials.gov