Radiofrequency (RF) Ablation for Atrial Fibrillation (AF) in Patients With Heart Failure With Preserved Ejection Fraction (AF-HFpEF)

This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction Read More

Inclusion Criteria:

• Age ≥ 50 years at date of consent.
• LVEF >50% as determined on imaging study measured in the last 6 calendar months prior to or on consent date.
• Hospitalized for HF within the past 12 calendar months prior to consent date.
• Stabilized patients defined as being off all IV therapies for at least 24 hours prior to consent date.
• Paroxysmal AF diagnosed within the past 6 calendar months or early persistent AF, defined as an AF episode lasting greater than 7 days but less than 6 calendar months prior to consent date.
• Indicated for oral anticoagulation according to current guidelines (CHA2DS2-VASc ≥ 2 in men or ≥ 3 in women at the time of consent)*
• Patient with CIED in situ at time of consent or scheduled to undergo ICM implant for AF management within 2 calendar months of randomization.

Exclusion Criteria:

• Previous catheter or surgical ablation of AF any time in the past.
• Long-standing persistent AF (>1-year prior to consent date) or permanent AF.
• Chronic pulmonary disease requiring home oxygen or oral/IV steroid therapy in the past 12 calendar months prior to consent date.
• Active infection at time of consent but may be re-considered for enrollment later after effective treatment.
• Left atrial size >50 mm as measured by echo in the past 6 calendar months prior to consent date.
• Untreated obstructive sleep apnea any time in past.
• Myocardial infarction in past 3 calendar months prior to consent date.
• Coronary artery bypass graft (CABG) surgery in past 3 calendar months prior to consent date.
• Stroke in past 3 calendar months prior to consent date.
• Intra-cardiac thrombus precluding ability to undergo AF ablation at time of consent but may be re-considered for enrollment later after effective treatment.
• Infiltrative cardiomyopathy (sarcoid, amyloid) any time in past.
• Active myocarditis at time of consent but may be re-considered for enrollment later after effective treatment.
• Hypertrophic cardiomyopathy at any time in past.
• Known pericardial constriction.
• Uncontrolled hypertension (SBP > 160 mmHg) at time of consent but may be re- considered for enrollment later after effective treatment.
• Untreated hypothyroidism or hyperthyroidism but may be re-considered for enrollment later after effective treatment.
• Pregnancy or nursing.
• Valvular AF or presence of a prosthetic valve.
• Undergoing dialysis or have advanced renal dysfunction (eGFR <30 ml/min/m2) defined as 3 times the upper limits of AST or ALT during the past 6 calendar months.
• Contraindication to anticoagulation.
• Metabolic derangements (e.g. renal/hepatic failure, electrolyte disturbance, etc.), prohibiting study (EP) study and ablation.
• Cognitive impairment.
• Life expectancy < 1 year following consent date.
• Unwilling to comply with all study protocol-required testing.
• Unwilling or unable to give informed consent.