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Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD

NCT00729911 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2019-04-10

No results posted yet for this study

Summary

1. To determine if catheter-based atrial fibrillation (AF) ablation is superior to Amiodarone treatment for symptomatic persistent/permanent AF in ICD/CRTD patients with an impaired left ventricular function.
2. Hypothesis: AF ablation is better than Amiodarone for subjects with symptomatic persistent or permanent AF and impaired LV function in terms of recurrence of AF, quality of life, 6-minute walk distance, EF and total number of hospitalizations.

Conditions

Interventions

PROCEDURE

Atrial Fibrillation ablation

Radio-frequency catheter ablation of atrial fibrillation

DRUG

Amiodarone

Taken orally on a daily basis.

Sponsors & Collaborators

  • Casa Sollievo della Sofferenza IRCCS

    collaborator OTHER

  • Catholic University, Italy

    collaborator OTHER

  • Southlake Regional Health Centre

    collaborator OTHER

  • Stanford University

    collaborator OTHER

  • University of Kansas

    collaborator OTHER

  • The University of Texas Medical Branch, Galveston

    collaborator OTHER

  • University of Foggia

    collaborator OTHER

  • Sutter Health

    collaborator OTHER

  • Texas Cardiac Arrhythmia Research Foundation

    lead OTHER

Principal Investigators

  • Andrea Natale, MD · Texas Cardiac Arrhythmia Research Foundation

  • Luigi Di Biase, MD, PhD · 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
2008-10-31
Primary Completion
2014-12-31
Completion
2015-12-31

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 NCT00729911 on ClinicalTrials.gov