Junctional AV Ablation in CRT-D: JAVA-CRT

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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Junctional AV Ablation in CRT-D Patients With Atrial Fibrillation (JAVA-CRT Trial)

Conditions
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Systolic Heart Failure, Atrial Fibrillation (Permanent)

Intervention / Treatment
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* Procedure: Atrioventricular junctional (AVJ) ablation
* Device: Cardiac resynchronization therapy - defibrillator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CRT-D<br>Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D). | Device: Cardiac resynchronization therapy - defibrillator<br>* Insertion of device capable of providing biventricular pacing and cardiac defibrillation<br>* Other names: CRT-D;|
| Experimental: CRT-D and AVJ Ablation<br>Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation. | Procedure: Atrioventricular junctional (AVJ) ablation<br>* RF energy delivery to AV node to create complete AV block<br>Device: Cardiac resynchronization therapy - defibrillator<br>* Insertion of device capable of providing biventricular pacing and cardiac defibrillation<br>* Other names: CRT-D;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Reduction ≥ 15% in Left Ventricular End-systolic Volume (LVESV) | Number of patients with reduction ≥ 15% in left ventricular end-systolic volume (LVESV) in each arm of the study. | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Left Ventricular Ejection Fraction (EF) | Change in left ventricular ejection fraction from baseline to 6 months. Units are expressed in percent and change may vary from -20% to 20%. More negative numbers are desired representing improvement from baseline to 6 months. | Baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, CRT, AV Junction Ablation, LVESV