Atrial Fibrillation Clinical Trial
Official title:
Exercise Capacity in Patients With Heart Failure With Preserved Ejection Fraction Before and After Ablation of Atrial Fibrillation
NCT number | NCT05376748 |
Other study ID # | 00001607 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 15, 2022 |
Est. completion date | December 30, 2024 |
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.
Status | Recruiting |
Enrollment | 34 |
Est. completion date | December 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 110 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Vermont Medical Center | Burlington | Vermont |
Lead Sponsor | Collaborator |
---|---|
University of Vermont |
United States,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Difference in peak VO2 in patient with vs. without chronic rate control | 4 months f/u cardiopulmonary exercise testing performance compared between those with and without chronic rate control | 4 months post-ablation | |
Primary | Change in peak VO2 | cardiopulmonary exercise testing will be performed & peak VO2 measured at baseline & follow up visit | before AF ablation and 4 months after AF ablation | |
Secondary | Change in KCCQ score | 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. | before and 4 months after AF ablation | |
Secondary | Percent change in NTproBNP | Initial sample taken day of AF ablation as is standard of care; reassessed at 4 month f/u visit | before and 4 months after AF ablation |
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