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no enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Vein Isolation (PVI) | Procedure | Subjects with clinical indication for PVI, either paroxysmal or persistent AF failing medical management with rate or rhythm control medications. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in LVESV by 15% or more from baseline at 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Remodeling as demonstrated by atrial & ventricular dimensions on echocardiogram | 6 months | |
| NYHA Class | 6 months | |
| Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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Patients seen in either the out patient or in hospital environment at St.Luke's-Roosevelt Hospital or The Valley Hospital, Ridgewood New Jersey, with systolic left ventricular dysfunction and atrial fibrillation. Class I-III CHF based on symptoms(shortness of breath,fatigue, peripheral edema and documented ejection fraction of less than 40%.
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| Name | Affiliation | Role |
|---|---|---|
| Suneet Mittal, MD | St. Luke's-Roosevelt Hospital Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Valley Hospital | Ridgewood | New Jersey | 07450 | United States | ||
| St.Luke's-Roosevelt Hospital |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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|
| 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 |
| New York |
| New York |
| 10025 |
| United States |
| D013514 |
| Surgical Procedures, Operative |