N/A
N=26
Junctional AV Ablation in CRT-D: JAVA-CRT
Systolic Heart Failure · Atrial Fibrillation (Permanent)
Bottom Line
View on ClinicalTrials.gov: NCT02946853 ↗Enrolled (actual)
26
Serious AEs
7.7%
Results posted
Jan 2022
Primary outcome: Primary: Number of Patients With Reduction ≥ 15% in Left Ventricular End-systolic Volume (LVESV) — 5; 6 Participants — p=1.00
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Atrioventricular junctional (AVJ) ablation (Procedure); Cardiac resynchronization therapy - defibrillator (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Reduction ≥ 15% in Left Ventricular End-systolic Volume (LVESV) |
5; 6 | 1.00 |
| SECONDARY Change in Left Ventricular Ejection Fraction (EF) |
-7.0; -8.6 | 0.974 |
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).
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
Data sourced from ClinicalTrials.gov (NCT02946853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.