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