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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
13
The intervention will involve standard of care electrophysiology ablation for rhythm management of atrial fibrillation with a procedure called a pulmonary vein isolation.
Inova Heart and Vascular Institute
Fairfax, Virginia, United States
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.
Time frame: 3, 6, 9, and 12 months from intervention
All-cause mortality
All deaths within 12 months of the intervention arm.
Time frame: 12 months
Number of cardiovascular mortalities
The number of deaths attributable to cardiovascular causes occurring within 12 months of the intervention arm
Time frame: 12 months
Number of all-cause hospitalizations
The total number of inpatient hospitalizations within 12 months following the intervention.
Time frame: 12 months
Number of heart failure hospitalizations
The total number of inpatient hospitalizations attributable to heart failure exacerbations within 12 months following the intervention.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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).
Time frame: 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.
Time frame: At baseline and 6 months post intervention