NCT07385417Recruiting
Electroporation Treatment for Early AF Management in Heart Failure With Preserved Ejection Fraction (HFpEF) Pilot Study
Source: ClinicalTrials.gov · Last updated 4 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 30 Nov 2023
- Start date
- 12 Apr 2023
- Primary completion date
- 12 Apr 2026
- Lead sponsor
- Cardioangiologisches Centrum Bethanien
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT07385417
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 12 Apr 2023 to the primary completion date, 12 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently participating in an interventional (drug, device, biologic, etc.) clinical trial
- Contraindication for AAD therapy
- Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
- Any cardiac surgery, myocardial infarction, PCI/PTCA or coronary artery stenting which occurred within the 3 months before the eligibility assessment
- Any cerebral ischemic event (strokes or TIAs) which occurred within the 3 months before the consent date
Other illness
- Any disease that limits life expectancy to less than one year
- Active systemic infection
- Reduced immune function or otherwise at high risk for infection per physician discretion
- Active malignancy or history of chemotherapy or radiation treatment
- Instable angina pectoris
- Primary pulmonary hypertension
- Any condition contraindicating chronic anticoagulation
- Presence of any cardiac prosthetic valves
Other
- Contraindications for PVI
- Thrombocytosis, thrombocytopenia
- Known pre-existing hemi-diaphragmatic paralysis
- Any untreated or uncontrolled hyperthyroidism or hypothyroidism
- Left atrial diameter \> 55 mm (anteroposterior) by TTE
- Presence of any pulmonary vein stents
- Presence of any pre-existing pulmonary vein stenosis (identified by CT or MRI and defined as at least 70% reduction of the PV diameter)
- Endocarditis, pericarditis or pericardial effusion
- Pregnant or breastfeeding women or women of childbearing potential not on adequate birth control.
- Substance abuse
- Unwilling to follow the study protocol and to attend follow-up visits
- \-
Who the study is looking for
- Seeking emergency (E) treatment including emergency room (ER) presentation
- Paroxysmal AF diagnosed according to current ESC guidelines
- 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.
- Age between 18 and 80 years
- Left atrial size, LA \< 55mm
- Left ventricular ejection fraction, EF \>50%
- Patients able to provide informed consent and willing to comply with all pre-, post- and follow up requirements as per study protocol -
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardioangiologisches Centrum Bethanien Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.