Actively Recruiting
Electroporation Treatment for Early AF Management in Heart Failure With Preserved Ejection Fraction (HFpEF) Pilot Study
Led by Cardioangiologisches Centrum Bethanien · Updated on 2026-02-04
200
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Electroporation Treatment for Early AF Management in Heart Failure With Preserved Ejection Fraction (HFpEF) Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Seeking emergency treatment including emergency room presentation
- Diagnosed with paroxysmal atrial fibrillation according to current ESC guidelines
- Diagnosed with heart failure with preserved ejection fraction (HFpEF) according to ESC guidelines 2021, including symptoms, ejection fraction >50%, and objective evidence of functional abnormality
- Age between 18 and 80 years
- Left atrial size less than 55 mm
- Left ventricular ejection fraction greater than 50%
- Able to provide informed consent and willing to comply with all study requirements
You will not qualify if you...
- Currently participating in another interventional clinical trial
- Any disease limiting life expectancy to less than one year
- Contraindications for pulmonary vein isolation (PVI)
- Contraindications for antiarrhythmic drug therapy
- Active systemic infection
- Thrombocytosis or thrombocytopenia
- Known pre-existing hemi-diaphragmatic paralysis
- Untreated or uncontrolled thyroid disorders
- Reduced immune function or high risk for infection
- Active malignancy or history of chemotherapy or radiation
- Prior left atrial ablation or surgical procedure including left atrial appendage closures
- Cardiac surgery, myocardial infarction, PCI/PTCA, or coronary stenting within 3 months before eligibility assessment
- Unstable angina pectoris
- Primary pulmonary hypertension
- Conditions contraindicating chronic anticoagulation
- Cerebral ischemic events (stroke or TIA) within 3 months before consent
- Presence of any cardiac prosthetic valves
- Left atrial diameter greater than 55 mm by transthoracic echocardiogram
- Presence of pulmonary vein stents
- Presence of pulmonary vein stenosis defined as at least 70% narrowing
- Endocarditis, pericarditis, or pericardial effusion
- Pregnant or breastfeeding women or women of childbearing potential not using adequate birth control
- Substance abuse
- Unwillingness to follow the study protocol and attend follow-up visits
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cardioangiologisches Centrum Bethanien
Frankfurt am Main, Germany, 60431
Actively Recruiting
Research Team
J
Julian Chun, Professor
CONTACT
B
Boris Scmidt, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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