SyncAV CRT Programming for Heart Failure

(SyncAV Trial)

Recruiting at 104 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

1686 Participants Needed

What You Need to Know Before You Apply

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.

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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

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. ^{2 4 5 6 10}

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. China pubmed.ncbi.nlm.nih.gov

[Effect of cardiac resynchronization therapy on cardiac function post A-V and V-V optimization]. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Dynamic atrioventricular delay programming improves ventricular electrical synchronization as evaluated by 3D vectorcardiography. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of atrioventricular and ventriculoventricular delay optimization on clinical and echocardiographic outcomes of patients treated with cardiac resynchronization therapy: a meta-analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Prospective comparison of echocardiographic atrioventricular delay optimization methods for cardiac resynchronization therapy. [2016]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Improvement of LV Reverse Remodeling Using Dynamic Programming of Fusion-Optimized Atrioventricular Intervals in Cardiac Resynchronization Therapy. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Cardiac resynchronization therapy: variations in echo-guided optimized atrioventricular and interventricular delays during follow-up. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Echocardiographic optimization of the atrioventricular and interventricular intervals during cardiac resynchronization. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Dynamic programming of atrioventricular delay improves electrical synchrony in a multicenter cardiac resynchronization therapy study. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

The effect of posture, exercise, and atrial pacing on atrioventricular conduction in systolic heart failure. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Optimization of Chronic Cardiac Resynchronization Therapy Using Fusion Pacing Algorithm Improves Echocardiographic Response. [2022]