Junctional AV Ablation in CRT-D: JAVA-CRT

University of Rochester

Status: Completed

Conditions: Systolic Heart Failure; Atrial Fibrillation (Permanent)

Treatments: Procedure: Atrioventricular junctional (AVJ) ablation; Device: Cardiac resynchronization therapy - defibrillator

Study type: Interventional

Funder types: Other

Identifiers

NCT02946853

RSRB00060626

Details and patient eligibility

About

Cardiac resynchronization therapy (CRT) is a demonstrably effective device intervention for patients with heart failure with reduced ejection fraction and specific indication. However, many patients with heart failure (HF) are unable to maintain sinus rhythm and approximately 30-36% of CRT patients are in atrial fibrillation (AF).

Full description

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).

Enrollment: 26 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

26 participants in 2 patient groups

CRT-D

Active Comparator group

Description:

Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D).

Treatment:

Device: Cardiac resynchronization therapy - defibrillator

CRT-D and AVJ Ablation

Experimental group

Description:

Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation.

Treatment:

Procedure: Atrioventricular junctional (AVJ) ablation

Device: Cardiac resynchronization therapy - defibrillator