Arrhythmia, Atrial Fibrillation, Congestive Heart Failure
Conditions
Keywords
Catheter Ablation, Atrial Fibrillation, Congestive heart failure
Brief summary
To compare heart function, symptoms, exercise capacity and quality of life in patients with Congestive Heart Failure (CHF) and Atrial Fibrillation (AF)before and after catheter ablation. Hypothesis: Restoration and maintenance of sinus rhythm by catheter ablation, without the use of antiarrhythmic drugs, in AF and CHF improves heart failure status.
Interventions
PROCEDUREPulmonary Vein Isolation (PVI)
Subjects with clinical indication for PVI, either paroxysmal or persistent AF failing medical management with rate or rhythm control medications.
Sponsors
St. Luke's-Roosevelt Hospital Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 years to 80 years * Clinical diagnosis of CHF based on symptoms (Shortness of breath, fatigue, peripheral edema) * Systolic left ventricular dysfunction with ejection fraction 40% or less * NYHA Class I, II or III heart failure * Paroxysmal AF(2 or more episodes in one month) that terminate within 7 days:or persistent AF (more than 7 days or less than 7 days but terminated with pharmacologic or electrical cardioversion). * Willing and able to sign informed consent
Exclusion criteria
* Previous ablation * Left atrial size greater than 60mm(parasternal view on transthoracic echocardiogram) * AF episodes triggered by another uniform arrhythmia(e.g.atrial flutter or atrial tachycardia) * Active alcohol or drug abuse, which may be causative of AF * Severe valvular disease requiring surgical repair * Myocardial infarction within 6 months of enrollment * Abnormality that prevents catheter introduction * Coronary surgical revascularization or other cardiac surgery within 6 months of enrollment * Patients in whom heart transplant expected with 6 months * AF deemed secondary to a transient or correctable cause (e.g.electrolyte imbalance ,trauma,recent surgery,,infection, toxic ingestion or endocrinopathy * Pregnancy or women of child bearing potential & not on reliable method of birth control * Contraindication to Warfarin therapy or other bleeding diathesis * Participation in another clinical trial * Inaccessable to follow-up * Life expectancy of less than 24 months caused by reasons other than heart disease * Renal failure requiring dialysis * Decompensated CHF within 48 Hours of enrollment * Second or third degree AV block or sinus pause greater than 3 seconds, resting heart rate less 30 bpm without a permanent pacemaker * A history of drug induced Torsades de Pointes or congenital long QT syndrome * Currently responding to antiarrhythmic drug therapy * Uninterrupted AF for more than 12 months prior to randomization unless sinus rhythm maintained for 24 hours or longer. * Unwilling or unable to sign informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in LVESV by 15% or more from baseline at 6 months | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NYHA Class | 6 months | — |
| Quality of Life | 6 months | — |
| Remodeling as demonstrated by atrial & ventricular dimensions on echocardiogram | 6 months | — |
| Hospitalization for HF | one year | Composite hospitalization for HF,thromboembolic complications, major bleeding or all cause mortality |
| Absence of Atrial fibrillation | one year | — |
| Six minute hall walk test | 6 months | — |
Countries
United States
Outcome results
None listed