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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation (AF)
• Intervention / Treatment: Procedure: AF Ablation

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julian Chun, Professor; Phone Number: +49 69 945028; Email: j.chun@ccb.de
• Study Contact Backup: Name: Boris Scmidt, Professor; Phone Number: +49 69 945028; Email: b.schmidt@ccb.de

Study Locations

• Germany
  • Frankfurt am Main, Germany, 60431
    • Recruiting
    • Cardioangiologisches Centrum Bethanien
    • Contact: Boris Schmidt, Dr.; Phone Number: 110 +4969945028; Email: b.schmidt@ccb.de
    • Principal Investigator: Boris Schmidt, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

    -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AF Ablation with electroporation; Patient in this arm will receive AF-Ablation	Procedure: AF Ablation; Atrial fibrillation ablation; Other Names: Medication or ECV
No Intervention: best medical AF treatment including rhythm and rate control (n=100); In this group patients reeive anti arrhythmia medication or ECV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint	composite of cardiovascular hospitalization, death, systemic embolism, stroke and emergency (E) treatment for cardiovascular reason.	within the study duration of 1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint	major bleeding requiring intervention, phrenic nerve palsy, pericardial tamponade, thromboembolic events, atrio-esophageal fistula, death	Within one year study

Collaborators and Investigators

• Sponsor: Cardioangiologisches Centrum Bethanien
• Investigators: Principal Investigator: Julian Chun, Professor, MVZ CCB

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2023
• Primary Completion (Estimated): April 12, 2026
• Study Completion (Estimated): April 12, 2026

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Electroporation Treatment for Early AF Management in Heart Failure with preserved Ejection Fraction (HFpEF) Pilot Study
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Pharmaceutical Preparations; Investigative Techniques; Technology, Pharmaceutical; Dosage Forms
• Other Study ID Numbers: 20221013 E-Team V.2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No