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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months following trial randomization
Awards & highlights
SyncAV Trial Summary
This trial will help determine if a certain type of CRT device is more effective than another in improving long-term response.
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.Check my eligibility
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.See study design
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.
SyncAV Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a new or upgraded CRT device implant without prior LV lead placement.
SyncAV Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months following trial randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months following trial randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduction in left ventricular end systolic volume (LVESV) between baseline and 12 months
Secondary outcome measures
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
SyncAV 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
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Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
640 Previous Clinical Trials
404,134 Total Patients Enrolled
Niraj Varma, MDPrincipal InvestigatorThe Cleveland Clinic
2 Previous Clinical Trials
1,658 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: SyncAV Arm
- Group 2: Fixed AV Delay Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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