Adaptive Cardiac Resynchronization Therapy (aCRT)

Study Status

Closed to Enrollment

Study Description

The Adaptive Cardiac Resynchronization Therapy (aCRT) study is a prospective, multi-center, randomized, double-blind, worldwide IDE (investigational device exemption) clinical trial designed to demonstrate the safety and efficacy of the aCRT device feature.

Cardiac resynchronization therapy (CRT) is accomplished by pacing both the left ventricle (LV) and right ventricle (RV) at short delays to provide synchronous ventricular contraction. CRT has been shown to improve clinical outcomes and survival rates and to result in reverse remodeling, a primary indicator of improved symptoms. Several studies, in fact, have shown that in CRT-indicated patients, LV pacing alone can provide similar improvements as biventricular pacing.

Several studies have demonstrated a significant correlation between cardiac function and atrioventricular (AV) and interventricular (VV) delays. Several other studies have provided evidence of the benefit of echo-guided AV and VV optimization. Optimization using echocardiography presents several challenges, including the need for different settings for resting and active stat

This study aims to demonstrate whether the aCRT feature provided in future CRT devices is equal to or an improvement upon echo optimization.

Sponsor

Medtronic

Key Eligibility

  • Patient is indicated for a CRT-D implant in the next 30 days
  • Intrinsic QRS duration ≥120ms within the last 30 days
  • LVEF ≤35% within the last six months
  • NYHA class III/IV within the last 30 days
  • Patient agrees to sign IRB and HIPPA consents and comply with the follow-ups
  • More detailed information is available from study staff.

    Principal Investigator

    Jim W. Cheung, MD

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    Contact Us

    For general inquiries, or if you need assistance finding a study, please contact:

    Robert Hagerty
    Subject Recruitment Manager
    Tel: (646) 962-9340
    [email protected]

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