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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Procedure: Atrial Fibrillation ablation; Drug: Amiodarone

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78758
      • Texas Cardiac Arrhythmia Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to Recurrence of AF lasting longer than 15 seconds	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Di Biase L, Mohanty P, Mohanty S, Santangeli P, Trivedi C, Lakkireddy D, Reddy M, Jais P, Themistoclakis S, Dello Russo A, Casella M, Pelargonio G, Narducci ML, Schweikert R, Neuzil P, Sanchez J, Horton R, Beheiry S, Hongo R, Hao S, Rossillo A, Forleo G, Tondo C, Burkhardt JD, Haissaguerre M, Natale A. Ablation Versus Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted Device: Results From the AATAC Multicenter Randomized Trial. Circulation. 2016 Apr 26;133(17):1637-44. doi: 10.1161/CIRCULATIONAHA.115.019406. Epub 2016 Mar 30.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: August 6, 2008
• First Submitted That Met QC Criteria: August 7, 2008
• First Posted (ESTIMATE): August 8, 2008

Study Record Updates

• Last Update Posted (ACTUAL): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Atrial fibrillation Ablation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Enzyme Inhibitors; Membrane Transport Modulators; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Sodium Channel Blockers; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Potassium Channel Blockers; Amiodarone
• Other Study ID Numbers: AATAC-AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED