Junctional AV Ablation in CRT-D: JAVA-CRT

Systolic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946853
• Other study ID #: RSRB00060626
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: August 31, 2020

Study information

• Verified date: December 2021
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation (Permanent)
• Heart Failure, Systolic
• Systolic Heart Failure

Intervention

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

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Emory Healthcare	Atlanta	Georgia
United States	Saint Alphonsus Regional Medical Center	Boise	Idaho
United States	SUNY at Buffalo	Buffalo	New York
United States	Lahey Clinic	Burlington	Massachusetts
United States	University of Iowa	Iowa City	Iowa
United States	Arkansas Cardiology	Little Rock	Arkansas
United States	Catholic Medical Ctr/New England Heart-Vasc Inst	Manchester	New Hampshire
United States	Northwell Hospital	New York	New York
United States	Huntington Memorial Hospital	Pasadena	California
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Portland VA Medical Center	Portland	Oregon
United States	University of Rochester Medical Center	Rochester	New York
United States	William Beaumont Hospital-Royal Oak	Royal Oak	Michigan
United States	Kootenai Heart Clinics, LLC	Spokane	Washington
United States	Multicare Institute for Research and Innovation	Tacoma	Washington
United States	INOVA	Woodbridge	Virginia
United States	University of Massachusetts-Worchester	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent Change in Left Ventricular End-diastolic Volume (LVEDV)	Percent change in left ventricular end-diastolic volume (LVEDV) by study arm.	Baseline to 6 months
Other	Number of Patients With Heart Failure Hospitalizations	Number of patients with heart failure hospitalizations in each arm of the study.	Baseline to 6 months
Other	Number of Patients With Implantable Cardioverter-defibrillator Delivered Inappropriate Therapy	Number of patients with implantable cardioverter-defibrillator delivered inappropriate therapy in each arm of the study	Baseline to 6 months
Other	Number of Patients With Implantable Cardioverter-defibrillator Delivered Appropriate Therapy for VT or VF	Number of patients with implantable cardioverter-defibrillator delivered appropriate therapy treatment by ICD for VT/VF in each arm of the study.	Baseline to 6 months
Other	Percentage of Biventricular Pacing	Amount of time that CRT is delivered	At 6 months
Other	Kansas City Cardiomyopathy Questionnaire	Scoring scale from 0 to 100. Higher scores represent better quality of life.	Baseline and 6 months
Other	Number of Participants With Episodes of Ventricular Fibrillation Following AV Junctional Ablation as Detected on ICD	Episodes of ventricular fibrillation following AV junctional ablation as detected on ICD in each arm of the study.	Baseline to one month
Primary	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	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