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