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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00729911
• Other study ID #: AATAC-AF
• Status: Completed
• Phase: Phase 4
• Start date: October 2008
• Est. completion date: December 2015

Study information

• Verified date: April 2019
• Source: Texas Cardiac Arrhythmia Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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,

2. 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.

3. Therapeutic anticoagulation for at least three weeks prior to initiation of therapy

4. Ability to complete 6 minute walk test.

5. 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).

6. All patients optimized on CHF medications including beta-blocker and ace-inhibitor or angiotensin-receptor blocker.

7. patients receiving low dose amiodarone- <200 mg for 2 or less months

Exclusion Criteria:

The exclusion criteria are:

1. Reversible causes of AF such as pericarditis, hyperthyroidism,

2. Presently with Valvular Heart disease requiring surgical intervention

3. Presently with coronary artery disease requiring surgical intervention

4. Early Post-operative AF (within three months of surgery)

5. Previous MAZE or left atrial instrumentation

6. Prolonged QT interval

7. Hypothyroidism

8. Liver Failure

9. Life expectancy <= 2 years

10. Social factors that would preclude follow up or make compliance difficult.

11. Contraindication to the use of anti-arrhythmic medications and/or coumadin and heparin

12. Enrollment in another investigational drug or device study.

13. Patients with severe pulmonary disease i.e. COPD or asthma

14. Documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction

15. Any ophthalmologic disorders (other than requiring glasses for vision correction)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure

Intervention

Procedure:
• Atrial Fibrillation ablation
Radio-frequency catheter ablation of atrial fibrillation

Drug:
• Amiodarone
Taken orally on a daily basis.

Locations

Country	Name	City	State
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas

Sponsors (9)

Lead Sponsor	Collaborator
Texas Cardiac Arrhythmia Research Foundation	Casa Sollievo della Sofferenza IRCCS, Catholic University, Italy, Southlake Regional Health Centre, Stanford University, Sutter Health, The University of Texas Medical Branch, Galveston, University of Foggia, University of Kansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Recurrence of AF lasting longer than 15 seconds		1 year
Secondary	Change in distance walked in 6-minute walk test		1 year
Secondary	Total number of hospitalizations during the trial period for each group		1 year
Secondary	Change in MLHF Quality of Life during trial period		1 year
Secondary	Change in EF during trial period		1 year