Junctional AV Ablation in CRT-D: JAVA-CRT

Launched by UNIVERSITY OF ROCHESTER · Oct 25, 2016

Keywords

ClinConnect Summary

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).

Gender

ALL

Eligibility criteria

• 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