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Cardiac Resynchronization Therapy Device

SyncAV CRT Programming for Heart Failure (SyncAV Trial)

N/A
Waitlist Available
Led By Niraj Varma, MD
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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:
Be older than 18 years old
Must not have
Undergone cardiac transplantation or have a classification of Status 1 for cardiac transplantation or consideration for transplantation during the study follow-up period
Prior His Bundle pacing implant or plan to have His Bundle pacing implant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months following trial randomization
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly listed here, side effects may include typical risks associated with CRT device implantation such as infection at the site of surgery, bleeding complications or issues related to improper pacing like dizziness or palpitations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a new or upgraded CRT device implant without prior LV lead placement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a heart transplant or am considered a top priority for one.
Select...
I have or will have a His Bundle pacing device implanted.
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I have had or plan to have heart vessel repair surgery recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months following trial randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months following trial randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduction in left ventricular end systolic volume (LVESV) between baseline and 12 months
Secondary study objectives
Percentage of CRT Responders at 12 months
Percentage of female subjects classified as CRT Responders at 12 months
Reduction in LVESV in female subjects between baseline and 12 months

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SyncAV ArmExperimental Treatment1 Intervention
Treatment Arm
Group II: Fixed AV Delay ArmActive Control1 Intervention
Control Arm

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Congestive Heart Failure (CHF) include pharmacologic therapies such as beta-blockers, ACE inhibitors, and ARBs, which help reduce the heart's workload and prevent further damage. Cardiac resynchronization therapy (CRT) devices, particularly those with SyncAV ON programming, optimize the timing of electrical impulses to improve heart muscle synchronization and enhance left ventricular (LV) reverse remodeling. This improved synchronization is vital for CHF patients as it enhances cardiac efficiency, reduces symptoms, and improves overall heart function and quality of life.

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
649 Previous Clinical Trials
409,460 Total Patients Enrolled
Niraj Varma, MDPrincipal InvestigatorThe Cleveland Clinic
2 Previous Clinical Trials
1,658 Total Patients Enrolled

Media Library

Congestive Heart Failure Research Study Groups: SyncAV Arm, Fixed AV Delay Arm
Congestive Heart Failure Clinical Trial 2023: Fixed AV delay Highlights & Side Effects. Trial Name: NCT04100148 — N/A
~174 spots leftby Jun 2025
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