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Junctional AV Ablation in CRT-D: JAVA-CRT

Primary Purpose

Systolic Heart Failure, Atrial Fibrillation (Permanent)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Atrioventricular junctional (AVJ) ablation
Cardiac resynchronization therapy - defibrillator
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systolic Heart Failure focused on measuring Atrial Fibrillation, CRT, AV Junction Ablation, LVESV

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Arkansas Cardiology
  • Huntington Memorial Hospital
  • Emory Healthcare
  • Saint Alphonsus Regional Medical Center
  • University of Iowa
  • Lahey Clinic
  • University of Massachusetts-Worchester
  • William Beaumont Hospital-Royal Oak
  • Catholic Medical Ctr/New England Heart-Vasc Inst
  • SUNY at Buffalo
  • Northwell Hospital
  • University of Rochester Medical Center
  • Oregon Health & Science University
  • Portland VA Medical Center
  • Abington Memorial Hospital
  • Drexel University College of Medicine
  • University of Pennsylvania
  • University of Pittsburgh Medical Center
  • INOVA
  • Kootenai Heart Clinics, LLC
  • Multicare Institute for Research and Innovation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CRT-D

CRT-D and AVJ Ablation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 24, 2016
Last Updated
December 31, 2021
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT02946853
Brief Title
Junctional AV Ablation in CRT-D: JAVA-CRT
Official Title
Junctional AV Ablation in CRT-D Patients With Atrial Fibrillation (JAVA-CRT Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systolic Heart Failure, Atrial Fibrillation (Permanent)
Keywords
Atrial Fibrillation, CRT, AV Junction Ablation, LVESV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRT-D
Arm Type
Active Comparator
Arm Description
Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D).
Arm Title
CRT-D and AVJ Ablation
Arm Type
Experimental
Arm Description
Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation.
Intervention Type
Procedure
Intervention Name(s)
Atrioventricular junctional (AVJ) ablation
Intervention Description
RF energy delivery to AV node to create complete AV block
Intervention Type
Device
Intervention Name(s)
Cardiac resynchronization therapy - defibrillator
Other Intervention Name(s)
CRT-D
Intervention Description
Insertion of device capable of providing biventricular pacing and cardiac defibrillation
Primary Outcome Measure Information:
Title
Number of Patients With Reduction ≥ 15% in Left Ventricular End-systolic Volume (LVESV)
Description
Number of patients with reduction ≥ 15% in left ventricular end-systolic volume (LVESV) in each arm of the study.
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Change in Left Ventricular Ejection Fraction (EF)
Description
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.
Time Frame
Baseline to 6 months
Other Pre-specified Outcome Measures:
Title
Percent Change in Left Ventricular End-diastolic Volume (LVEDV)
Description
Percent change in left ventricular end-diastolic volume (LVEDV) by study arm.
Time Frame
Baseline to 6 months
Title
Number of Patients With Heart Failure Hospitalizations
Description
Number of patients with heart failure hospitalizations in each arm of the study.
Time Frame
Baseline to 6 months
Title
Number of Patients With Implantable Cardioverter-defibrillator Delivered Inappropriate Therapy
Description
Number of patients with implantable cardioverter-defibrillator delivered inappropriate therapy in each arm of the study
Time Frame
Baseline to 6 months
Title
Number of Patients With Implantable Cardioverter-defibrillator Delivered Appropriate Therapy for VT or VF
Description
Number of patients with implantable cardioverter-defibrillator delivered appropriate therapy treatment by ICD for VT/VF in each arm of the study.
Time Frame
Baseline to 6 months
Title
Percentage of Biventricular Pacing
Description
Amount of time that CRT is delivered
Time Frame
At 6 months
Title
Kansas City Cardiomyopathy Questionnaire
Description
Scoring scale from 0 to 100. Higher scores represent better quality of life.
Time Frame
Baseline and 6 months
Title
Number of Participants With Episodes of Ventricular Fibrillation Following AV Junctional Ablation as Detected on ICD
Description
Episodes of ventricular fibrillation following AV junctional ablation as detected on ICD in each arm of the study.
Time Frame
Baseline to one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan S Steinberg, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Cardiology
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Huntington Memorial Hospital
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Emory Healthcare
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Saint Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
University of Massachusetts-Worchester
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
William Beaumont Hospital-Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Catholic Medical Ctr/New England Heart-Vasc Inst
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03102
Country
United States
Facility Name
SUNY at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Northwell Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Portland VA Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19008
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
INOVA
City
Woodbridge
State/Province
Virginia
ZIP/Postal Code
22191
Country
United States
Facility Name
Kootenai Heart Clinics, LLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Multicare Institute for Research and Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35043250
Citation
Steinberg JS, Gorcsan J, Mazur A, Jain SK, Rashtian M, Greer GS, Zarraga I, Vloka M, Cook MM, Salam T, Mountantonakis S, Beck H, Silver J, Aktas M, Henrikson C, Schaller RD, Epstein AE, McNitt S, Schleede S, Peterson D, Goldenberg I, Zareba W. Junctional AV ablation in patients with atrial fibrillation undergoing cardiac resynchronization therapy (JAVA-CRT): results of a multicenter randomized clinical trial pilot program. J Interv Card Electrophysiol. 2022 Aug;64(2):519-530. doi: 10.1007/s10840-021-01116-6. Epub 2022 Jan 18.
Results Reference
derived

Learn more about this trial

Junctional AV Ablation in CRT-D: JAVA-CRT

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