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SyncAV Post-Market Trial

Title CRD_973 SyncAV Post-Market Trial
Therapeutic Area Heart Failure
Principal Investigator Munther Homoud, MD
Min Age 18 Years
Gender All
Contact Munther Homoud
More Information


This study will examine how effective the SyncAV feature of Abbott’s cardiac resynchronization therapy device is in treating heart failure.

Study Details

Inclusion Criteria

  • Scheduled to receive a new CRT implant or an upgrade (Abbott CRT device and Abbott Quadripolar LV lead) from an existing implantable cardioverter defibrillator/pacemaker implant with no more than 10% RV pacing at the last device interrogation, no prior LV lead placement, AND meet the following additional criteria:
    • Mild to severe heart failure despite optimal medical therapy for at least 3 months prior to signing
    • LVEF ≤ 35% based on a prior standard of care echocardiogram
    • Left bundle branch block (LBBB) as documented on an ECG.

Exclusion Criteria

  • Recent myocardial infarction or unstable angina within 40 days prior to signing consent
  • Recent cardiac revascularization (angioplasty, stent or bypass graft) in the 4 weeks prior to signing consent or planned within 3 months following consent
  • Cerebrovascular accident or transient ischemic attack in the 3 months prior to signing consent

Study Requirements

It is expected that patients will be in this research study for approximately 14 months.

They will be asked to return to the clinic 4 times after the device implant. Each visit will take approximately 20 to 60 minutes depending on if their device is programmed with SyncAV or with standard settings. They are expected to complete all required follow-up visits.