Junctional AV Ablation in CRT-D: JAVA-CRT

• ClinicalTrials.gov Identifier: NCT02946853
• Recruitment Status: Completed
• First Posted: October 27, 2016
• Last Update Posted: November 3, 2020
• Sponsor: University of Rochester
• Information provided by (Responsible Party): Jonathan S. Steinberg, University of Rochester

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Systolic Heart Failure; Atrial Fibrillation (Permanent)	Procedure: Atrioventricular junctional (AVJ) ablation; Device: Cardiac resynchronization therapy - defibrillator	Not Applicable

Detailed 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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Junctional AV Ablation in CRT-D Patients With Atrial Fibrillation (JAVA-CRT Trial)
• Actual Study Start Date: October 1, 2016
• Actual Primary Completion Date: August 31, 2020
• Actual Study Completion Date: August 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: CRT-D; 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; Insertion of device capable of providing biventricular pacing and cardiac defibrillation; Other Name: CRT-D
Experimental: CRT-D and AVJ Ablation; Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation.	Procedure: Atrioventricular junctional (AVJ) ablation; RF energy delivery to AV node to create complete AV block; Device: Cardiac resynchronization therapy - defibrillator; Insertion of device capable of providing biventricular pacing and cardiac defibrillation; Other Name: CRT-D

Outcome Measures

Primary Outcome Measures :

1. Number of patients with reduction ≥ 15% in left ventricular end-systolic volume (LVESV) [ Time Frame: Baseline to 6 months ]

Secondary Outcome Measures :

1. Number of patients with improvement in left ventricular ejection fraction (EF) [ Time Frame: Baseline to 6 months ]

Other Outcome Measures:

1. Number of patients with improvement in left ventricular end-diastolic volume (LVEDV) [ Time Frame: Baseline to 6 months ]
2. Number of patients with heart failure hospitalizations [ Time Frame: Baseline to 6 months ]
3. Number of patients with implantable cardioverter-defibrillator delivered inappropriate therapy [ Time Frame: Baseline to 6 months ]
4. Number of patients with implantable cardioverter-defibrillator delivered appropriate therapy for ventricular tachycardia (VT) or ventricular fibrillation (VF) [ Time Frame: Baseline to 6 months ]
5. Percentage of biventricular pacing [ Time Frame: Baseline to 6 months ]
6. Kansas City Cardiomyopathy Questionnaire [ Time Frame: Baseline to 6 months ]
7. Episodes of ventricular fibrillation following AV junctional ablation as detected on ICD [ Time Frame: Baseline to one month ]

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Massachusetts

Lahey Clinic

Burlington, Massachusetts, United States, 01805

Sponsors and Collaborators

University of Rochester

More Information

• Responsible Party: Jonathan S. Steinberg, Professor of Medicine - Cardiology, University of Rochester
• ClinicalTrials.gov Identifier: NCT02946853
• Other Study ID Numbers: RSRB00060626
• First Posted: October 27, 2016
• Last Update Posted: November 3, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Jonathan S. Steinberg, University of Rochester:

Atrial Fibrillation; CRT; AV Junction Ablation; LVESV

Additional relevant MeSH terms:

Atrial Fibrillation; Heart Failure, Systolic; Heart Failure; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes