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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Texas Cardiac Arrhythmia Research Foundation
Sponsor:
Collaborators:
Casa Sollievo della Sofferenza IRCCS
Catholic University, Italy
Southlake Regional Health Centre
Stanford University
University of Kansas
The University of Texas, Galveston
University of Foggia
Sutter Health
Information provided by (Responsible Party):
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier:
NCT00729911
First received: August 6, 2008
Last updated: November 21, 2014
Last verified: November 2014
  Purpose
  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 Intervention Phase
Heart Failure
Procedure: Atrial Fibrillation ablation
Drug: Amiodarone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Texas Cardiac Arrhythmia Research Foundation:

Primary Outcome Measures:
  • Time to Recurrence of AF lasting longer than 15 seconds [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in distance walked in 6-minute walk test [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Total number of hospitalizations during the trial period for each group [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in MLHF Quality of Life during trial period [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in EF during trial period [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729911

Contacts
Contact: Luigi Di Biase 216-773-3879 Luigi.Dibiase@stdavids.com
Contact: Deb Cardinal 512-458-9410 dscardinal@austinheartbeat.com

Locations
United States, Texas
Texas Cardiac Arrhythmia Research Foundation Recruiting
Austin, Texas, United States, 78758
Contact: Andrea Natale    512-458-9410    dscardinal@austinheartbeat.com   
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, Galveston
University of Foggia
Sutter Health
Investigators
Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia Research Foundation
Principal Investigator: Luigi Di Biase, MD, PhD Texas Cardiac Arrhythmia Research Foundation
  More Information

No publications provided

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
Study First Received: August 6, 2008
Last Updated: November 21, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Failure
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014