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Exercise Capacity Before and After AF Ablation in Patients With HFpEF

Exercise Capacity in Patients With Heart Failure With Preserved Ejection Fraction Before and After Ablation of Atrial Fibrillation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05376748
Enrollment
34
Registered
2022-05-17
Start date
2022-04-15
Completion date
2024-12-30
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Heart Failure With Preserved Ejection Fraction

Keywords

Ablation, HFpEF, atrial fibrillation, exercise capacity, peak oxygen consumption

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AF (defined as AF after a 12-week post-procedural blanking period accounting for post-ablation inflammation) will be withdrawn from the study and not proceed to the 4 month follow up visit.

Interventions

None listed

Sponsors

University of Vermont
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in peak VO2before AF ablation and 4 months after AF ablationcardiopulmonary exercise testing will be performed & peak VO2 measured at baseline & follow up visit

Secondary

MeasureTime frameDescription
Change in KCCQ scorebefore and 4 months after AF ablationKansas 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 NTproBNPbefore and 4 months after AF ablationInitial sample taken day of AF ablation as is standard of care; reassessed at 4 month f/u visit

Other

MeasureTime frameDescription
Difference in peak VO2 in patient with vs. without chronic rate control4 months post-ablation4 months f/u cardiopulmonary exercise testing performance compared between those with and without chronic rate control

Countries

United States

Contacts

Primary ContactNicole Habel, MD
nicole.habel@uvmhealth.org8028470000
Backup ContactAmy Henderson
amy.henderson@uvmhealth.org

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026