Catheter Ablation for Atrial Fibrillation and Heart Failure

Study Overview
=================
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.

Official Title
-----------------
Pulmonary Vein Isolation for Rhythm Control in Patients With Atrial Fibrillation and Left Ventricular Dysfunction: A Pilot Study

Conditions
-----------------
Congestive Heart Failure, Atrial Fibrillation, Arrhythmia

Intervention / Treatment
-----------------
* Procedure: Pulmonary Vein Isolation (PVI)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Optimal Medical therapy<br>Subjects with Class I,IIor III congestive heart failure on optimal medical therapy. Planned catheter ablation for paroxysmal or persistent atrial fibrillation. Paroxysmal AF defined as recurrent AF(2 or more episodes in one month) that terminate within seven days. Persistent AF defined as sustained beyond seven days, or lasting less than seven days but requiring pharmacologic or electrical cardioversion. | Procedure: Pulmonary Vein Isolation (PVI)<br>* Subjects with clinical indication for PVI, either paroxysmal or persistent AF failing medical management with rate or rhythm control medications.<br>* Other names: Catheter Ablation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in LVESV by 15% or more from baseline at 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remodeling as demonstrated by atrial & ventricular dimensions on echocardiogram |  | 6 months | 
| NYHA Class |  | 6 months | 
| Quality of Life |  | 6 months | 
| Six minute hall walk test |  | 6 months | 
| Hospitalization for HF | Composite hospitalization for HF,thromboembolic complications, major bleeding or all cause mortality | one year | 
| Absence of Atrial fibrillation |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Catheter Ablation, Atrial Fibrillation, Congestive heart failure