Electroporation for early AF treatment in people with HFpEF

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, single-center feasibility pilot enrolling 200 patients with symptomatic paroxysmal AF and HFpEF. Per protocol, 100 patients will undergo FARAPULSE electroporation pulmonary vein isolation (PVI) and 100 will receive standard medical treatment for AF. All patients will receive detailed informed consent including risks, benefits, and study rationale before randomization, with follow-up to capture symptoms, rhythm outcomes, and safety events. The study aims to determine feasibility and preliminary comparative outcomes of electroporation PVI versus medical therapy in this HFpEF population.

Why it matters

Who can join: the full rules

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
11. Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
12. Any cardiac surgery, myocardial infarction, PCI/PTCA or coronary artery stenting which occurred within the 3 months before the eligibility assessment
13. Instable angina pectoris
14. Primary pulmonary hypertension
15. Any condition contraindicating chronic anticoagulation
16. Any cerebral ischemic event (strokes or TIAs) which occurred within the 3 months before the consent date
17. Presence of any cardiac prosthetic valves
18. Left atrial diameter \> 55 mm (anteroposterior) by TTE
19. Presence of any pulmonary vein stents
20. Presence of any pre-existing pulmonary vein stenosis (identified by CT or MRI and defined as at least 70% reduction of the PV diameter)
21. Endocarditis, pericarditis or pericardial effusion
22. Pregnant or breastfeeding women or women of childbearing potential not on adequate birth control.
23. Substance abuse
24. Unwilling to follow the study protocol and to attend follow-up visits

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Where it's running

• Cardioangiologisches Centrum Bethanien
  Frankfurt am Main, Germany Recruiting

Study contacts

• Principal investigator: Julian Chun, Professor — Mvz Ccb
• Study coordinator: Julian Chun, Professor
• Email: j.chun@ccb.de
• Phone: +49 69 945028

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.