NCT02946853

Junctional AV Ablation in CRT-D: JAVA-CRT

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Systolic Heart Failure
• Atrial Fibrillation (Permanent)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-10-01
• Primary completion: 2020-08-31
• Completion: 2020-08-31
• First posted: 2016-10-27
• Last updated: 2022-01-25
• Results posted: 2022-01-25

Locations

21 sites across 1 country: United States