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Junctional AV Ablation in CRT-D: JAVA-CRT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02946853
Recruitment Status : Recruiting
First Posted : October 27, 2016
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Jonathan S. Steinberg, University of Rochester

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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)
Study Start Date : October 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


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




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 ]


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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

Information from the National Library of Medicine

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


Contacts
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Contact: Jonathan S Steinberg, MD 973-436-4155 jsteinberg@smgnj.com
Contact: Wojciech Zareba, MD, PhD 585-275-5391 wojciech_zareba@urmc.rochester.edu

Locations
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United States, Massachusetts
Lahey Clinic Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Jonathan Silver, MD         
Sponsors and Collaborators
University of Rochester

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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: October 8, 2019
Last Verified: October 2019
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:
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Atrial Fibrillation
Heart Failure, Systolic
Heart Failure
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes