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RECRUITING
NCT07385417
NA

Electroporation Treatment for Early AF Management in Heart Failure With Preserved Ejection Fraction (HFpEF) Pilot Study

Sponsor: Cardioangiologisches Centrum Bethanien

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

AF Ablation

Atrial fibrillation ablation

Locations (1)

Cardioangiologisches Centrum Bethanien

Frankfurt am Main, Germany