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Electroporation Treatment for Early AF Management in Heart Failure With Preserved Ejection Fraction (HFpEF) Pilot Study | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT07385417•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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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 diastolic dysfunction, NT-proBNP (non acute setting): sinus rhythm: 125pg/ml or AF: 365pg/ml, vs. acute HF: \>450 pg/ml if aged \<55 years, \>900 pg/ml if aged between 55 and 75 years and \>1800 pg/ml if \>75ys.
•4. Age between 18 and 80 years
•5. Left atrial size, LA \< 55mm
•6. Left ventricular ejection fraction, EF \>50%
•7. Patients able to provide informed consent and willing to comply with all pre-, post- and follow up requirements as per study protocol -

Exclusion Criteria

•1. Currently participating in an interventional (drug, device, biologic, etc.) clinical trial
•2. Any disease that limits life expectancy to less than one year
•3. Contraindications for PVI
•4. Contraindication for AAD therapy
•5. Active systemic infection
•6. Thrombocytosis, thrombocytopenia
•7. Known pre-existing hemi-diaphragmatic paralysis
•8. Any untreated or uncontrolled hyperthyroidism or hypothyroidism
•9. Reduced immune function or otherwise at high risk for infection per physician discretion
•10. Active malignancy or history of chemotherapy or radiation treatment
+15 more criteria

Locations (1)

Cardioangiologisches Centrum Bethanien

Frankfurt am Main, Germany

Key Dates

Start Date

April 12, 2023

Primary Completion Date

April 12, 2026

Completion Date

April 12, 2026

Last Updated

February 4, 2026

Enrollment

200

ESTIMATED participants

Conditions

Atrial Fibrillation (AF)

Interventions

AF Ablation

PROCEDURE

Contacts

Julian Chun, Professor

CONTACT

+49 69 945028 j.chun@ccb.de

Boris Scmidt, Professor

CONTACT

+49 69 945028 b.schmidt@ccb.de

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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