Exercise Capacity Before and After AF Ablation in Patients With HFpEF

Recruiting

• Conditions: Heart Failure With Preserved Ejection Fraction; Atrial Fibrillation

• Registration Number: NCT05376748
• Lead Sponsor: University of Vermont

Brief Summary

In a prospective, observational pilot study of patients scheduled for an atrial fibrillation (AF) ablation at the University of Vermont Medical Center the investigators will compare exercise capacity before and four months after AF ablation.

Detailed Description

Patients ≥ 18 years of age who are scheduled for an AF ablation at the University of Vermont Medical Center will be screened for the following inclusion criteria: H2FpEF score of ≥ 6 (corresponding to ≥90% probability of HFpEF (19)) AND echocardiogram within the past 2 years that reported a LV ejection fraction ≥ 50% AND at least one symptom of HF (dyspnea on exertion, orthopnea or paroxysmal nocturnal dyspnea). Exclusion criteria: (1) Life expectancy \<12 months, (2) moderate or more valvular disease, (3) inability to walk on a treadmill. Patients with early recurrent AF (defined as AF after a 12-week post-procedural blanking period accounting for post-ablation inflammation) will be withdrawn from the study and not proceed to the 4 month follow up visit.

Study Timeline

• Study Start: 2022-04-15
• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-17
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• H2FpEF score of ≥ 6 (corresponding to >90% probability of HFpEF (19))
• echocardiogram within the past 2 years that reported a LV ejection fraction ≥ 50%
• at least one symptom of HF (dyspnea on exertion, orthopnea or paroxysmal nocturnal dyspnea).
• AF ablation scheduled at UVMMC

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Exclusion Criteria

• Life expectancy <12 months
• moderate or more valvular disease
• inability to walk on a treadmill

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in peak VO2	before AF ablation and 4 months after AF ablation	cardiopulmonary exercise testing will be performed \& peak VO2 measured at baseline \& follow up visit

Secondary Outcome Measures

Name	Time	Method
Change in KCCQ score	before and 4 months after AF ablation	Kansas City Cardiomyopathy Questionnaire (KCCQ) will be obtained at baseline visit \& again at ablation follow up visit. Scale 0-100 with higher scores signifying better quality of life.
Percent change in NTproBNP	before and 4 months after AF ablation	Initial sample taken day of AF ablation as is standard of care; reassessed at 4 month f/u visit

Trial Locations

Locations (1)

University of Vermont Medical Center; 🇺🇸 Burlington, Vermont, United States