Catheter Ablation for Atrial Fibrillation and Heart Failure
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.
|Congestive Heart Failure Atrial Fibrillation Arrhythmia||Procedure: Pulmonary Vein Isolation (PVI)|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Pulmonary Vein Isolation for Rhythm Control in Patients With Atrial Fibrillation and Left Ventricular Dysfunction: A Pilot Study|
- Improvement in LVESV by 15% or more from baseline at 6 months [ Time Frame: 6 months ]
- Remodeling as demonstrated by atrial & ventricular dimensions on echocardiogram [ Time Frame: 6 months ]
- NYHA Class [ Time Frame: 6 months ]
- Quality of Life [ Time Frame: 6 months ]
- Six minute hall walk test [ Time Frame: 6 months ]
- Hospitalization for HF [ Time Frame: one year ]Composite hospitalization for HF,thromboembolic complications, major bleeding or all cause mortality
- Absence of Atrial fibrillation [ Time Frame: one year ]
|Study Start Date:||April 2010|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Optimal Medical therapy
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)
Subjects with clinical indication for PVI, either paroxysmal or persistent AF failing medical management with rate or rhythm control medications.
Other Name: Catheter Ablation
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082601
|United States, New Jersey|
|The Valley Hospital|
|Ridgewood, New Jersey, United States, 07450|
|United States, New York|
|New York, New York, United States, 10025|
|Principal Investigator:||Suneet Mittal, MD||St. Luke's-Roosevelt Hospital Center|