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

Sponsor

Texas Cardiac Arrhythmia Research Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT00729911

Collaborator

Casa Sollievo della Sofferenza IRCCS (Other), Catholic University, Italy (Other), Southlake Regional Health Centre (Other), Stanford University (Other), University of Kansas (Other), The University of Texas Medical Branch, Galveston (Other), University of Foggia (Other), Sutter Health (Other)

203

Enrollment

Location

Arms

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.
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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Procedure: Atrial Fibrillation ablation Drug: Amiodarone	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

203 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Ablation vs. Amiodarone for Treatment of Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted ICD/CRTD

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: AF ablation Subjects assigned to the catheter ablation strategy will undergo catheter based AF ablation. The goal of the procedure is to achieve isolation of all 4 pulmonary veins. Subjects assigned to receive Amiodarone will have the oral medication initiated in an clinic setting.	Procedure: Atrial Fibrillation ablation Radio-frequency catheter ablation of atrial fibrillation
Active Comparator: Amiodarone Amiodarone is taken orally on a daily basis.	Drug: Amiodarone Taken orally on a daily basis.

Arm

Intervention/Treatment

Active Comparator: AF ablation

Subjects assigned to the catheter ablation strategy will undergo catheter based AF ablation. The goal of the procedure is to achieve isolation of all 4 pulmonary veins. Subjects assigned to receive Amiodarone will have the oral medication initiated in an clinic setting.

Procedure: Atrial Fibrillation ablation

Radio-frequency catheter ablation of atrial fibrillation

Active Comparator: Amiodarone

Amiodarone is taken orally on a daily basis.

Drug: Amiodarone

Taken orally on a daily basis.

Outcome Measures

Primary Outcome Measures

Time to Recurrence of AF lasting longer than 15 seconds [1 year]

Secondary Outcome Measures

Change in distance walked in 6-minute walk test [1 year]
Total number of hospitalizations during the trial period for each group [1 year]
Change in MLHF Quality of Life during trial period [1 year]
Change in EF during trial period [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with an dual chamber ICD or CRTD (with an existing functional atrial lead) with remote monitoring capabilities and EF <= 40% within the last 3 months by echocardiogram, nuclear imaging, MRI or cardiac catheterization,
Persistent or chronic symptomatic AF resistant to anti-arrhythmic medication other than Amiodarone. Resistant defined as recurrent AF of greater than 5 minutes duration at least once per month.
Therapeutic anticoagulation for at least three weeks prior to initiation of therapy
Ability to complete 6 minute walk test.
Age >= 18 years old. (Females must be either post-menopausal >12 months, practicing a protocol-acceptable method of birth control [defined as injectable or implantable hormonal contraceptives, oral contraceptives, intrauterine device, diaphragm plus spermicide], or have had a hysterectomy, bilateral oophorectomy, or tubal ligation performed at least 6 months prior to enrollment).
All patients optimized on CHF medications including beta-blocker and ace-inhibitor or angiotensin-receptor blocker.
patients receiving low dose amiodarone- <200 mg for 2 or less months

Exclusion Criteria:

The exclusion criteria are:

Reversible causes of AF such as pericarditis, hyperthyroidism,
Presently with Valvular Heart disease requiring surgical intervention
Presently with coronary artery disease requiring surgical intervention
Early Post-operative AF (within three months of surgery)
Previous MAZE or left atrial instrumentation
Prolonged QT interval
Hypothyroidism
Liver Failure
Life expectancy <= 2 years
Social factors that would preclude follow up or make compliance difficult.
Contraindication to the use of anti-arrhythmic medications and/or coumadin and heparin
Enrollment in another investigational drug or device study.
Patients with severe pulmonary disease i.e. COPD or asthma
Documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction
Any ophthalmologic disorders (other than requiring glasses for vision correction)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas	United States	78758

Investigators

Principal Investigator: Andrea Natale, MD, Texas Cardiac Arrhythmia Research Foundation
Principal Investigator: Luigi Di Biase, MD, PhD, Texas Cardiac Arrhythmia Research Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andrea Natale, Executive Medical Director, Texas Cardiac Arrhythmia Research Foundation

ClinicalTrials.gov Identifier:

NCT00729911

Other Study ID Numbers:

AATAC-AF

First Posted:

Aug 8, 2008

Last Update Posted:

Apr 10, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD: