Status:
COMPLETED
Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD
Lead Sponsor:
Texas Cardiac Arrhythmia Research Foundation
Collaborating Sponsors:
Casa Sollievo della Sofferenza IRCCS
Catholic University, Italy
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 f...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT00729911
Start Date
October 1 2008
End Date
December 1 2015
Last Update
April 10 2019
Active Locations (1)
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1
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78758