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

Cardioangiologisches Centrum Bethanien

Status: Enrolling

Conditions: Atrial Fibrillation (AF)

Treatments: Procedure: AF Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT07385417

20221013 E-Team V.2

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

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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Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

AF Ablation with electroporation

Active Comparator group

Description:

Patient in this arm will receive AF-Ablation

Treatment:

Procedure: AF Ablation

best medical AF treatment including rhythm and rate control (n=100)

No Intervention group

Description:

In this group patients reeive anti arrhythmia medication or ECV