Ablation Versus Medical Management of Atrial Fibrillation in HFpEF

Prior treatment

• Previous left heart ablation procedure for AF
• Contraindication to chronic anticoagulation therapy or heparin
• Cardiac surgery, angioplasty, or cerebrovascular accident within 4 weeks prior to enrollment.

Other illness

• Acute coronary syndrome within 4 weeks as defined by electrocardiographic (ECG) ST segment depression or prominent T-wave inversion and/or positive biomarkers of necrosis (e.g. troponin) in the absence of ST-segment elevation and in an appropriate clinical setting (chest discomfort or angina equivalent).
• Listed for heart transplant
• Cardiac assist device implanted or need for mechanical hemodynamic support or inpatient admission
• Uncontrolled hypertension, defined as resting systolic blood pressure >190 and/or resting diastolic pressure>110
• Cardiac diagnosis in addition to or other than HFpEF:
• Severe valvular disease
• Complex congenital heart disease
• Severe pulmonary hypertension (RVSP > 60 mmHg), not secondary to HFpEF
• Non-cardiac pulmonary edema

Lab values

• Chronic Kidney Disease (CKD) stage 4-5 (GFR<25 ml/min/1.73m2), or on hemodialysis

Other

• Longstanding atrial fibrillation, defined here as greater than 3 years of persistent atrial fibrillation
• Severe left atrial dilatation, with LA length > 6.0 cm, optimally from parasternal long view
• Planned cardiovascular intervention
• Life expectancy less than 1 year
• Active myocarditis
• Hypertrophic obstructive cardiomyopathy
• Restrictive or constrictive cardiomyopathy, including known amyloidosis, sarcoidosis, hemochromatosis
• Constrictive pericarditis
• Clinical evidence of digoxin toxicity
• Sepsis
• Inability to comply with planned study procedures
• Pregnancy or nursing mothers
• Uncontrolled hypothyroidism or hyperthyroidism
• BMI of >65 kg/m2

• between 18 to 90 years of age, male or female
• Left Ventricular Ejection Fraction (LVEF) > 50% by echocardiogram during routine screening or within 12 months prior to enrollment day.
• Symptoms of heart failure requiring treatment with diuretic therapy for at least 30 days preceding enrollment.
• Symptomatic paroxysmal or persistent atrial fibrillation.
• Paroxysmal atrial fibrillation defined as recurrent AF (at least 2 episodes) that terminated spontaneously within 7 days
• Persistent AF was defined as AF which is sustained beyond 7 days, or lasting less than 7 days but necessitating pharmacologic or electrical cardioversion
• Included within the category of persistent AF is "long-standing persistent AF" defined as continuous AF of greater than 1 year in duration
• AF episodes had to be documented in the last 3 months prior to enrollment by ECG, Holter monitor, Loop recorder, memory of the implanted device, or any suitable device.
• Current symptoms of heart failure (NYHA II-IV) at the enrollment visit (Visit 1)
• Structural heart disease evidenced by one or both of the following echocardiographic findings (done during the transthoracic echocardiography (TTE) within 6 months of enrollment)
• Left atrial enlargement (LAE) defined as LA width > 3.8 cm or LA length > 5.0 cm, or LA area > 20 cm2 or LA volume > 55 mL or LA volume index > 29 ml/m2. (of note, LA length greater than 6.0 cm will be excluded)
• Left ventricular hypertrophy (LVH) defined by septal thickness or posterior wall thickness > 1.0 cm
• And at least one of the following:
• A heart failure hospitalization lasting over 12 hours and including intravenous diuretics at a healthcare facility within 12 months prior to the enrollment visit.
• An elevated pro-brain natriuretic peptide (BNP) (>100 pg/mL, or N-terminal pro b-type natriuretic peptide (NT-proBNP)>300 pg/mL)
• Hemodynamic testing consistent with HFpEF physiology including pulmonary capillary wedge pressure (PCWP) (or LVEDP) ≥ 15 mmHg.