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

Inclusion criteria

• 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 -

Exclusion criteria

• Currently participating in an interventional (drug, device, biologic, etc.) clinical trial
• Any disease that limits life expectancy to less than one year
• Contraindications for PVI
• Contraindication for AAD therapy
• Active systemic infection
• Thrombocytosis, thrombocytopenia
• Known pre-existing hemi-diaphragmatic paralysis
• Any untreated or uncontrolled hyperthyroidism or hypothyroidism
• Reduced immune function or otherwise at high risk for infection per physician discretion
• Active malignancy or history of chemotherapy or radiation treatment
• 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
• Instable angina pectoris
• Primary pulmonary hypertension
• Any condition contraindicating chronic anticoagulation
• Any cerebral ischemic event (strokes or TIAs) which occurred within the 3 months before the consent date
• Presence of any cardiac prosthetic valves
• 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

-