SyncAV CRT Programming for Heart Failure
(SyncAV Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new programming method for heart devices in people with heart failure who do not benefit enough from their current treatment. It compares a new setting, SyncAV, with the usual settings to determine if it improves heart function over time. Individuals with heart failure, a specific heart rhythm issue called left bundle branch block, and who are receiving a new heart device may qualify for this trial. Participants must adhere to the trial's follow-up schedule. As an unphased trial, this study allows participants to contribute to innovative research that could enhance heart device programming for future patients.
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 prior data suggests that these CRT devices are safe for heart failure patients?
Research shows that SyncAV pacing, a technique used to enhance heart function in certain medical devices, is generally well-tolerated. Studies indicate that SyncAV can improve the efficiency of the heart's electrical signals, potentially leading to better health outcomes for individuals with heart conditions. Although specific safety data for SyncAV is not available, its design aims to optimize heart device settings, suggesting it is considered safe. For those considering joining a trial, it may be reassuring to know that SyncAV has been used to help improve survival rates.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it explores new ways to optimize cardiac resynchronization therapy (CRT) for heart failure patients. Unlike traditional fixed AV delay settings, the SyncAV programming automatically adjusts the timing of electrical impulses to each patient's needs, potentially improving heart function and patient outcomes. This personalized approach could lead to better synchronization of heart muscle contractions, offering hope for more effective management of heart failure symptoms compared to current standard CRT options.
What evidence suggests that this trial's treatments could be effective for heart failure?
Research has shown that SyncAV ON programming in cardiac resynchronization therapy (CRT) can significantly reduce hospital visits for heart failure. One study found a 30% decrease in hospitalizations for patients using SyncAV ON compared to those with standard CRT. In this trial, participants in the SyncAV Arm will receive this programming. Additionally, all patients in the study experienced a narrowing of their QRS complex, part of the heart's electrical activity, with SyncAV ON. This change is associated with better health outcomes. These findings suggest that SyncAV ON could improve heart function and reduce hospital visits for heart failure patients.36789
Who Is on the Research Team?
Niraj Varma, MD
Principal Investigator
The Cleveland Clinic
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- Fixed AV delay
- SyncAV programmed ON
Trial Overview
The SyncAV Post-Market Trial tests if setting CRT devices to 'SyncAV ON' improves heart function better than traditional fixed AV delay settings by observing changes in the left ventricle's size and function over time.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Treatment Arm
Control Arm
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
Citations
Gain in real-world cardiac resynchronization therapy ...
SyncAV ON programming was associated with a significant reduction in cumulative HFH rate (HR 0.70; 95% CI 0.55–0.89; P = .003). The proportion ...
Gain in real-world cardiac resynchronization therapy ...
This large, real-world, propensity score–matched study demonstrates that SyncAV CRT is associated with significantly reduced HFHs and associated costs.
Gain in real-world cardiac resynchronization therapy ...
This large, real-world, propensity score-matched study demonstrates that SyncAV CRT is associated with significantly reduced HFHs and associated costs.
4.
cardiovascular.abbott
cardiovascular.abbott/us/en/hcp/products/cardiac-rhythm-management/blog/sync-av-acheives-narrowest-qrs-results.htmlPart 1: SyncAV CRT Technology
100% of patients had a narrower QRS when SyncAV CRT technology was turned on1 and CRT-induced QRS narrowing has been shown to improve clinical outcomes for ...
Progress in Cardiac Resynchronisation Therapy and ...
MPP IDE trial [71]: programming to pace from distal poles (MPP-AS) presents better clinical outcomes and is more likely to convert non- ...
Optimization of Chronic Cardiac Resynchronization ...
Recent published data reported a significant QRS narrowing with programming of SyncAV in existing CRT devices as determined acutely by 12-lead ECG, but did ...
SyncAV CRT Programming for Heart Failure
The research does not provide specific safety data for SyncAV CRT Programming, but it discusses the importance of optimizing atrioventricular (AV) and ...
Clinical outcomes of automatic algorithms in cardiac ...
Automatic algorithms that change AV or VV intervals did not improve mortality, heart failure hospitalizations, or cardiovascular symptoms in patients with ...
Study Details | NCT04100148 | SyncAV Post-Market Trial
The SyncAV Post-Market Trial is a prospective, randomized, multi-center trial performed to determine if cardiac resynchronization therapy (CRT) devices ...
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