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

NCT00729911 | Completed Phase 4

• 1 other identifier: AATAC-AF
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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

Heart Failure

Keywords

Atrial fibrillation Ablation

Outcome Measures

Primary Outcomes (1)

• Time to Recurrence of AF lasting longer than 15 seconds

  1 year

Secondary Outcomes (4)

• 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

Study Arms (2)

AF ablation

ACTIVE COMPARATOR

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

Amiodarone

ACTIVE COMPARATOR

Amiodarone is taken orally on a daily basis.

Drug: Amiodarone

Interventions

Atrial Fibrillation ablation PROCEDURE

Radio-frequency catheter ablation of atrial fibrillation

AF ablation

Amiodarone DRUG

Taken orally on a daily basis.

Amiodarone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78758, United States

Location

Related Publications (1)

• 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.

  PMID: 27029350 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Andrea Natale, MD

  Texas Cardiac Arrhythmia Research Foundation

  PRINCIPAL INVESTIGATOR

• Luigi Di Biase, MD, PhD

  Texas Cardiac Arrhythmia Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Medical Director

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 8, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

US (1)