Clinical trial NCT02946853: 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
Overall status: COMPLETED
Phase: NA
Conditions: Systolic Heart Failure
Atrial Fibrillation (Permanent)
Keywords: Atrial Fibrillation
CRT
AV Junction Ablation
LVESV
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2016-10-27
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Number of Patients With Reduction ≥ 15% in Left Ventricular End-systolic Volume (LVESV)
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in Left Ventricular Ejection Fraction (EF)
timeFrame: Baseline to 6 months
Other outcomes:
measure: Percent Change in Left Ventricular End-diastolic Volume (LVEDV)
timeFrame: Baseline to 6 months
measure: Number of Patients With Heart Failure Hospitalizations
timeFrame: Baseline to 6 months
measure: Number of Patients With Implantable Cardioverter-defibrillator Delivered Inappropriate Therapy
timeFrame: Baseline to 6 months
measure: Number of Patients With Implantable Cardioverter-defibrillator Delivered Appropriate Therapy for VT or VF
timeFrame: Baseline to 6 months
measure: Percentage of Biventricular Pacing
timeFrame: At 6 months
measure: Kansas City Cardiomyopathy Questionnaire
timeFrame: Baseline and 6 months
measure: Number of Participants With Episodes of Ventricular Fibrillation Following AV Junctional Ablation as Detected on ICD
timeFrame: Baseline to one month
Locations:
city: Little Rock
country: United States
facility: Arkansas Cardiology
state: Arkansas
city: Pasadena
country: United States
facility: Huntington Memorial Hospital
state: California
city: Atlanta
country: United States
facility: Emory Healthcare
state: Georgia
city: Boise
country: United States
facility: Saint Alphonsus Regional Medical Center
state: Idaho
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts-Worchester
state: Massachusetts
city: Royal Oak
country: United States
facility: William Beaumont Hospital-Royal Oak
state: Michigan
city: Manchester
country: United States
facility: Catholic Medical Ctr/New England Heart-Vasc Inst
state: New Hampshire
city: Buffalo
country: United States
facility: SUNY at Buffalo
state: New York
city: New York
country: United States
facility: Northwell Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Woodbridge
country: United States
facility: INOVA
state: Virginia
city: Spokane
country: United States
facility: Kootenai Heart Clinics, LLC
state: Washington
city: Tacoma
country: United States
facility: Multicare Institute for Research and Innovation
state: Washington
Study officials:
affiliation: University of Rochester
name: Jonathan S Steinberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.