Electroporation for early AF treatment in people with HFpEF
Electroporation Treatment for Early AF Management in Heart Failure With Preserved Ejection Fraction (HFpEF) Pilot Study
NA · Cardioangiologisches Centrum Bethanien · NCT07385417
This study will test whether electroporation pulmonary vein isolation using the FARAPULSE system works better than usual medical treatment for people with symptomatic paroxysmal atrial fibrillation who also have HFpEF.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Cardioangiologisches Centrum Bethanien (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Frankfurt am Main) |
| Trial ID | NCT07385417 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults 18–80 years old with symptomatic paroxysmal AF, HFpEF (EF >50%), left atrial diameter <55 mm, and no contraindication to pulmonary vein isolation who can provide informed consent.
Not a fit: Patients with persistent or long-standing AF, major comorbidities limiting life expectancy, contraindications to PVI, or concurrent enrollment in other interventional trials are unlikely to benefit from this pilot.
Why it matters
Potential benefit: If successful, the electroporation procedure could reduce AF episodes and symptoms and potentially improve quality of life for people with HFpEF.
How similar studies have performed: Pulsed-field electroporation (FARAPULSE) has shown promising safety and rhythm outcomes in prior AF studies, but its focused use in HFpEF patients is novel and not well studied.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Frankfurt am Main
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation, Electroporation Treatment for Early AF Management in Heart Failure with preserved Ejection Fraction Pilot Study