SyncAV CRT Programming for Heart Failure

(SyncAV Trial)

Not currently recruiting at 124 trial locations

Overseen By Awais Humayun, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Must be taking: Beta-blockers, ACE inhibitors

Disqualifiers: Recent MI, Unstable angina, AF, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

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

Willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Your heart's electrical activity shows certain patterns that may not be safe for the study.

I have heart failure and have been on the best possible medication for over 3 months.

Exclusion Criteria

You have had a previous CRT device implanted.

Pregnant or breastfeeding at the time of signing consent

I have had a heart transplant or am considered a top priority for one.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Physicians implant an Abbott CRT device and Abbott Quadripolar LV lead with any available right atrial and right ventricular leads

1 day

1 visit (in-person)

Randomization and Initial Programming

Subjects are randomized to either SyncAV CRT programmed ON or fixed AV delay arm, and devices are programmed accordingly

2-6 weeks post-implantation

1 visit (in-person)

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

12 months

3 visits (in-person) at 3, 6, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary and secondary outcomes measured at 12 months

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?

Group I: SyncAV Arm Experimental Treatment 1 Intervention

Treatment Arm

Group II: Fixed AV Delay Arm Active Control 1 Intervention

Control Arm

Who Is Running the Clinical Trial?

Abbott Medical Devices

Lead Sponsor

Trials

659

Recruited

420,000+

Founded

1888

Headquarters

Abbott Park, Illinois, USA

Known For

Medical Devices Innovation

Top Products

FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs

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

1. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(21)00423-9/fulltext

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 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1547527121004239

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.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33965608/

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.html

Part 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10607614/

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- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7067690/

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 ...

7. withpower.com withpower.com/trial/syncav-crt-programming-for-heart-failure-3f196

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 ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2666501823002209

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 ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04100148

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 ...