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

Recruiting N/A Interventional Study
Atrial Fibrillation (AF)
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Cardioangiologisches Centrum Bethanien · Other
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About This Trial
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 treatm…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Seeking emergency (E) treatment including emergency room (ER) presentation 2. Paroxysmal AF diagnosed according to current ESC guidelines 3. Diagnosis of HFpEF according to ESC guidelines 2021 (clinical symptoms, EF\>50%, objective evidence of functional abnormality: LV diast…
Contacts

Julian Chun, Professor

+49 69 945028

j.chun@ccb.de

CONTACT

Boris Scmidt, Professor

+49 69 945028

b.schmidt@ccb.de

CONTACT