Ablation Versus Medical Management of Atrial Fibrillation in HFpEF

Inclusion Criteria:

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.

Exclusion Criteria:

Previous left heart ablation procedure for AF
Contraindication to chronic anticoagulation therapy or heparin
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
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).
Cardiac surgery, angioplasty, or cerebrovascular accident within 4 weeks prior to enrollment.
Planned cardiovascular intervention
Listed for heart transplant
Cardiac assist device implanted or need for mechanical hemodynamic support or inpatient admission
Life expectancy less than 1 year
Uncontrolled hypertension, defined as resting systolic blood pressure >190 and/or resting diastolic pressure>110
Chronic Kidney Disease (CKD) stage 4-5 (GFR<25 ml/min/1.73m2), or on hemodialysis
Cardiac diagnosis in addition to or other than HFpEF:
Active myocarditis
Hypertrophic obstructive cardiomyopathy
Severe valvular disease
Restrictive or constrictive cardiomyopathy, including known amyloidosis, sarcoidosis, hemochromatosis
Complex congenital heart disease
Constrictive pericarditis
Severe pulmonary hypertension (RVSP > 60 mmHg), not secondary to HFpEF
Non-cardiac pulmonary edema
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