Exercise Capacity Before and After AF Ablation in Patients With HFpEF

NCT ID: NCT05376748

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 34 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-15
• Study Completion Date: 2024-12-30

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AF (defined as AF after a 12-week post-procedural blanking period accounting for post-ablation inflammation) will be withdrawn from the study and not proceed to the 4 month follow up visit.

Conditions

Heart Failure With Preserved Ejection Fraction; Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Nicole Habel, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicole Habel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

University of Vermont Medical Center

Burlington, Vermont, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nicole Habel, MD

Role: CONTACT

nicole.habel@uvmhealth.org

8028470000

Amy Henderson

Role: CONTACT

amy.henderson@uvmhealth.org

Facility Contacts

Nicole Habel, MD

Role: primary

nicole.habel@uvmhealth.org

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Other Identifiers

00001607

Identifier Type: -

Identifier Source: org_study_id