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

Texas Cardiac Arrhythmia Research Foundation1 site in 1 country203 target enrollmentOctober 2008

ConditionsHeart Failure

InterventionsAtrial Fibrillation ablation Amiodarone

DrugsAmiodarone

Overview

Phase: Phase 4
Intervention: Atrial Fibrillation ablation
Conditions: Heart Failure
Sponsor: Texas Cardiac Arrhythmia Research Foundation
Enrollment: 203
Locations: 1
Primary Endpoint: Time to Recurrence of AF lasting longer than 15 seconds
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

December 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Texas Cardiac Arrhythmia Research Foundation

Responsible Party

Principal Investigator

Andrea Natale

Executive Medical Director

Texas Cardiac Arrhythmia Research Foundation

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: Atrial Fibrillation ablation