Junctional AV Ablation in CRT-D: JAVA-CRT
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ClinicalTrials.gov Identifier: NCT02946853 |
Recruitment Status :
Completed
First Posted : October 27, 2016
Last Update Posted : November 3, 2020
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Condition or disease | Intervention/treatment | Phase |
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Systolic Heart Failure Atrial Fibrillation (Permanent) | Procedure: Atrioventricular junctional (AVJ) ablation Device: Cardiac resynchronization therapy - defibrillator | Not Applicable |
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 |

Arm | Intervention/treatment |
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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).
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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.
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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 |
- Number of patients with reduction ≥ 15% in left ventricular end-systolic volume (LVESV) [ Time Frame: Baseline to 6 months ]
- Number of patients with improvement in left ventricular ejection fraction (EF) [ Time Frame: Baseline to 6 months ]
- Number of patients with improvement in left ventricular end-diastolic volume (LVEDV) [ Time Frame: Baseline to 6 months ]
- Number of patients with heart failure hospitalizations [ Time Frame: Baseline to 6 months ]
- Number of patients with implantable cardioverter-defibrillator delivered inappropriate therapy [ Time Frame: Baseline to 6 months ]
- Number of patients with implantable cardioverter-defibrillator delivered appropriate therapy for ventricular tachycardia (VT) or ventricular fibrillation (VF) [ Time Frame: Baseline to 6 months ]
- Percentage of biventricular pacing [ Time Frame: Baseline to 6 months ]
- Kansas City Cardiomyopathy Questionnaire [ Time Frame: Baseline to 6 months ]
- Episodes of ventricular fibrillation following AV junctional ablation as detected on ICD [ Time Frame: Baseline to one month ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946853
United States, Massachusetts | |
Lahey Clinic | |
Burlington, Massachusetts, United States, 01805 |
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 Key Record Dates |
Last Update Posted: | November 3, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Atrial Fibrillation CRT AV Junction Ablation LVESV |
Atrial Fibrillation Heart Failure, Systolic Heart Failure Heart Diseases |
Cardiovascular Diseases Arrhythmias, Cardiac Pathologic Processes |