SyncAV CRT Programming for Heart Failure
(SyncAV Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing a special setting in heart devices called SyncAV ON to help patients with new heart devices. It aims to improve how well their hearts pump blood by adjusting the timing of electrical signals in the heart.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications. However, it mentions that participants should be on optimal medical therapy, including beta-blockers and other heart medications, for at least 3 months before joining. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment SyncAV CRT Programming for Heart Failure?
Research shows that using SyncAV with cardiac resynchronization therapy (CRT) leads to better heart function and patient outcomes compared to traditional methods. Patients with SyncAV had more significant improvements in heart size and function, and more of them experienced relief from heart failure symptoms.12345
Is SyncAV CRT Programming for Heart Failure safe for humans?
The research does not provide specific safety data for SyncAV CRT Programming, but it discusses the importance of optimizing atrioventricular (AV) and ventriculoventricular (VV) delays in cardiac resynchronization therapy (CRT) to improve heart function. While safety is not directly addressed, these optimizations are part of standard CRT practices, suggesting they are generally considered safe when properly managed.13467
How does the SyncAV CRT treatment for heart failure differ from other treatments?
The SyncAV CRT treatment is unique because it dynamically adjusts the timing of the heart's electrical signals to improve synchronization, unlike traditional fixed-timing methods. This personalized approach adapts to each patient's changing needs, potentially enhancing the effectiveness of cardiac resynchronization therapy.278910
Research Team
Niraj Varma, MD
Principal Investigator
The Cleveland Clinic
Eligibility Criteria
This trial is for adults with heart failure who have a specific ECG pattern, intact AV conduction, and are on optimal heart failure medication. They must be getting a new CRT device or upgrading to an Abbott CRT system without prior LV lead placement. Exclusions include recent heart issues, stroke, certain procedures within the last few months, persistent AF, pregnancy, limited life expectancy or other conflicting clinical trials.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Implantation
Physicians implant an Abbott CRT device and Abbott Quadripolar LV lead with any available right atrial and right ventricular leads
Randomization and Initial Programming
Subjects are randomized to either SyncAV CRT programmed ON or fixed AV delay arm, and devices are programmed accordingly
Treatment and Optimization
For SyncAV ON arm, optimization of SyncAV feature at 3 and 6 months; for fixed AV delay arm, programming at BiV pacing nominal settings
Follow-up
Participants are monitored for safety and effectiveness after treatment, with primary and secondary outcomes measured at 12 months
Treatment Details
Interventions
- Fixed AV delay
- SyncAV programmed ON
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abbott Medical Devices
Lead Sponsor
Dr. Etahn Korngold
Abbott Medical Devices
Chief Medical Officer
Medical training at Harvard Medical School and Massachusetts General Hospital
Robert B. Ford
Abbott Medical Devices
Chief Executive Officer since 2020
Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business