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

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ClinicalTrials.gov Identifier: NCT00729911
Recruitment Status : Active, not recruiting
First Posted : August 8, 2008
Last Update Posted : October 19, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Heart Failure Procedure: Atrial Fibrillation ablation Drug: Amiodarone Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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 : October 2008
Primary Completion Date : December 2014
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Outcome Measures

Primary Outcome Measures :
  1. Time to Recurrence of AF lasting longer than 15 seconds [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Change in distance walked in 6-minute walk test [ Time Frame: 1 year ]
  2. Total number of hospitalizations during the trial period for each group [ Time Frame: 1 year ]
  3. Change in MLHF Quality of Life during trial period [ Time Frame: 1 year ]
  4. Change in EF during trial period [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729911

United States, Texas
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78758
Sponsors and Collaborators
Texas Cardiac Arrhythmia Research Foundation
Casa Sollievo della Sofferenza IRCCS
Catholic University, Italy
Southlake Regional Health Centre
Stanford University
University of Kansas
The University of Texas Medical Branch, Galveston
University of Foggia
Sutter Health
Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia Research Foundation
Principal Investigator: Luigi Di Biase, MD, PhD Texas Cardiac Arrhythmia Research Foundation
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrea Natale, Executive Medical Director, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier: NCT00729911     History of Changes
Other Study ID Numbers: AATAC-AF
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Andrea Natale, Texas Cardiac Arrhythmia Research Foundation:
Atrial fibrillation Ablation

Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors