Atrial Fibrillation (AF)
Conditions
Keywords
Electroporation Treatment for Early AF Management in Heart Failure with preserved Ejection Fraction (HFpEF) Pilot Study
Brief summary
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.
Interventions
PROCEDUREAF Ablation
Atrial fibrillation ablation
Sponsors
Cardioangiologisches Centrum Bethanien
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint | within the study duration of 1 Year | composite of cardiovascular hospitalization, death, systemic embolism, stroke and emergency (E) treatment for cardiovascular reason. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoint | Within one year study | major bleeding requiring intervention, phrenic nerve palsy, pericardial tamponade, thromboembolic events, atrio-esophageal fistula, death |
Countries
Germany
Contacts
CONTACTJulian Chun, Professor
CONTACTBoris Scmidt, Professor
PRINCIPAL_INVESTIGATORJulian Chun, Professor
MVZ CCB
Outcome results
None listed