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enrollment was not keeping up with technology advancements. PI felt the data would not be pertinent
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| Name | Class |
|---|---|
| Biosense Webster, Inc. | INDUSTRY |
| Medtronic | INDUSTRY |
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This is a prospective non-blinded randomized control pilot study comparing the effect of pulmonary vein isolation against medical management of atrial fibrillation in patients with Heart Failure with preserved Ejection Fraction (HFpEF).
Recent studies using PVI for rhythm control in patients with heart failure with reduced ejection fraction (HFrEF) have shown improvement in systolic ejection fraction, exercise capacity, quality of life, and a significant reduction in all-cause mortality. The PVI procedure has been shown to be safe and comparably effective in treating Atrial Fibrillation (AF) in HFpEF patients, but no studies have yet demonstrated the effects of catheter ablation on exercise capacity or clinical outcomes.
The investigators propose a prospective, non-blinded randomized control pilot study to assess the feasibility of conducting larger scale studies to determine if there are differences between catheter ablation with medical management on exercise capacity and quality of life in HFpEF patients with AF. The investigators' study will be powered for AF burden reduction, and the investigators hope to use the effect size on exercise capacity and heart failure events to help determine power for larger clinical studies that will follow to shed light on how invasive management of atrial fibrillation may impact the natural history of individuals with these two cardiovascular conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary Vein Isolation (PVI) Group | Experimental | Subjects randomized to this treatment arm will undergo atrial fibrillation ablation, and undergo routine post-procedural follow-up. |
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| Medical Management | No Intervention | Subjects randomized to this treatment arm will undergo medical management of the arrhythmia, but will not undergo invasive electrophysiologic procedures to address subject's AF. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Vein Isolation | Procedure | The intervention will involve standard of care electrophysiology ablation for rhythm management of atrial fibrillation with a procedure called a pulmonary vein isolation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in AF burden as assessed by difference in percentage of time an individual is in AF | AF burden, described as the percentage of time an individual is in AF relative to the total amount of time analyzed. This outcome will be assessed at multiple intervals following intervention arm, using a continuous, implantable heart rhythm monitor. The investigators' focus will be on the change between pre-intervention AF burden and AF burden at 6 month follow-up. | 3, 6, 9, and 12 months from intervention |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | All deaths within 12 months of the intervention arm. | 12 months |
| Number of cardiovascular mortalities | The number of deaths attributable to cardiovascular causes occurring within 12 months of the intervention arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brett Atwater, MD | Inova Heart and Vascular Institute | Study Chair |
| Eunice Yang, MD PhD | Inova Heart and Vascular Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inova Heart and Vascular Institute | Fairfax | Virginia | 22031 | United States |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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2:1 randomization to catheter ablation (PVI) or to medical management.
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Serum biomarkers, atrial fibrillation burden, anatomical and functional echocardiographic parameters, and exercise capacity will all be measured and analyzed by study personnel blinded to the patient's intervention.
|
| 12 months |
| Number of all-cause hospitalizations | The total number of inpatient hospitalizations within 12 months following the intervention. | 12 months |
| Number of heart failure hospitalizations | The total number of inpatient hospitalizations attributable to heart failure exacerbations within 12 months following the intervention. | 12 months |
| Change in patient-reported quality of life as assessed by Kansas City Cardiomyopathy Questionnaire | The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. A change of 10 points or more is considered not only clinically significant but also carries prognostic implications for event-free survival in heart failure patients. | At enrollment (baseline) and 6 months following intervention |
| Change in NT pro-BNP levels | Serum biomarker associated with congestive heart failure symptoms, measured in (mg/ml). | At enrollment (baseline) and 6 months following intervention |
| Change in exercise capacity as assessed by the 6 minute walk distance test | Pre-intervention arm and 6 month post-procedural exercise capacity will be assessed using change in 6 minute walk distance, defined as the total distance (in meters) traversed during 6 minutes of time. This is well-validated measure of functional capacity and prognostic marker in patients with heart failure. | At baseline and 6 months post intervention |
| D013568 |
| Pathological Conditions, Signs and Symptoms |