Ablation vs. Medical management of atrial fibrillation in heart failure with Preserved Ejection fRaction and its effects on Exercise capacity (AMPERE): A pilot study

To determine if PVI in the HFpEF population leads to effective AF burden reduction and to demonstrate feasibility in conducting a prospective single-center non-blinded randomized control trial comparing the effects of catheter ablation of AF against medical management. Feasibility is defined as both efficacy of PVI procedure in the HFpEF population in reducing the AF burden-the proportion of time the patients are in atrial fibrillation relative to total amount of recorded time-as well as the logistics involved in carrying out a single-center randomized control study involving PVI in HFpEF patients.

Inova Fairfax Medical Center 
3300 Gallows Rd  
Falls Church, VA, 22042

• LVEF >45% by echocardiogram during routine screening or within 12 months prior to enrollment  day.
• 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 6 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)
• one or more of the following findings
  • Left atrial enlargement (LAE) defined in accordance with the American Society of 
    Echocardiography guidelines accounting for gender differences in cut-offs for left atrial size parameters of LA width, LA length, LA area, and LA volume. (i.e. LA width > 3.8 cm in women, > 4.0 cm in men) done during the TTE within 12 months of enrollment)
  • Left ventricular hypertrophy (LVH) defined by septal thickness or posterior wall thickness >1.0 cm done during the TTE within 12 months of enrollment)
  • 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-BNP (>100 pg/mL, or NT-proBNP>200 pg/mL)
  • Hemodynamic testing consistent with HFpEF physiology including PCWP (or LVEDP) ≥ 15 mmHg within 12 months prior to enrollment
  • Symptoms if heart failure requiring treatment with diuretics therapy preceding enrollment

• Unable/unwilling to get implantable loop monitor
• Absolute Contraindication to anticoagulation therapy or heparin
• Cardiac surgery, angioplasty, or cerebrovascular accident within 4 weeks prior to enrollment.
• Planned cardiovascular intervention within 2 months after enrollment
• Listed for heart transplant
• Cardiac assist
• 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