Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD
This study is currently recruiting participants.
Verified October 2009 by Texas Cardiac Arrhythmia Research Foundation
Sponsor:
Texas Cardiac Arrhythmia Research Foundation
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: July 25, 2012
Last verified: October 2009
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Purpose
- 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.
- 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: | August 2014 |
| Estimated Primary Completion Date: | August 2013 (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:
- 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.
Exclusion Criteria:
The exclusion criteria are:
- 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)
Contacts and Locations
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: | July 25, 2012 |
| 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 Heart Diseases Cardiovascular Diseases Pathologic Processes Amiodarone |
Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vasodilator Agents |
ClinicalTrials.gov processed this record on May 23, 2013