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Electroporation Treatment for Early AF Management in Heart Failure With Preserved Ejection Fraction (HFpEF) Pilot Study
Sponsor: Cardioangiologisches Centrum Bethanien
Summary
The proposed pilot study is a prospective, randomized, single-center feasibility study, enrolling 200 patients with symptomatic paroxysmal AF. Per protocol, 100 patients will undergo a FARAPULSE electroporation PVI and 100 patients will receive standard AF medical treatment. Prior enrollment, all patients will be informed on the risk and benefits of the PVI procedure as well as the medical treatment. In addition, particular information on the rationale of the study, including a detailed risk/benefit analysis, will be provided to all patients.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2023-04-12
Completion Date
2026-04-12
Last Updated
2026-02-04
Healthy Volunteers
No
Conditions
Interventions
AF Ablation
Atrial fibrillation ablation
Locations (1)
Cardioangiologisches Centrum Bethanien
Frankfurt am Main, Germany