Junctional AV Ablation in CRT-D: JAVA-CRT

This study is designed to evaluate if patients with AF indicated for CRT will have
significant reduction in left ventricular end-systolic volume when randomized to
atrioventricular junction (AVJ) ablation. In this study, subjects will be randomized to
receive CRT-D or CRT-D with AVJ ablation. Randomization will be stratified by enrolling
center (1:1 ratio).

Inclusion Criteria:

- Optimal pharmacologic therapy is defined by published guidelines from the American
Heart Association and the American College of Cardiology

- Initial implantation of CRT-D or prior implantation of CRT-D within one year

- Ischemic or nonischemic cardiomyopathy

- LVEF ≤ 35%

- NYHA class II-IV (ambulatory)

- QRS ≥ 120 ms for LBBB and ≥ 150 ms for non-LBBB patients

- Continuous AF > 3 months when no further efforts to restore sinus rhythm are feasible
or pursued

Exclusion Criteria:

- Ventricular rate > 110 bpm at rest despite maximal medical therapy

- Ventricular rate < 50 bpm at rest

- Heart block/symptomatic bradycardia that necessitates permanent pacing

- Acute coronary syndrome or coronary artery bypass surgery within 12 weeks

- Severe aortic or mitral valvular heart disease

- Prior AVJ ablation

- Any medical condition likely to limit survival to < 1 year

- Patients with ACC/AHA Stage D refractory Class IV symptoms listed for transplant or
requiring inotropic support

- Contraindication to systematic anticoagulation

- Renal failure requiring dialysis

- AF due to reversible cause e.g. hyperthyroid state

- Pregnancy

- Participation in other clinical trials that will affect the objectives of this study

- History of non-compliance to medical therapy

- Inability or unwillingness to provide informed consent

- Patients with short-lived AF or those in sinus rhythm are ineligible