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Cardiac Resynchronization Therapy Device

SyncAV CRT Programming for Heart Failure (SyncAV Trial)

N/A
Recruiting
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 below
Select...
I am scheduled for a new or upgraded CRT device implant without prior LV lead placement.

SyncAV Trial 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

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

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
638 Previous Clinical Trials
402,788 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the sample size of those receiving treatment in this clinical trial?

"In order to undertake this medical trial, Abbott Medical Devices is recruiting 1400 eligible patients from South Texas Cardiovascular Consultants in San Antonio, TX and HonorHealth in Scottsdale AZ."

Answered by AI

Can participants still join this experiment?

"Affirmative. Clinicaltrials.gov reveals that this medical research is recruiting subjects, having been initially posted on October 3rd 2019 and last updated November 9th 2022. The trial needs 1,400 participants from 45 sites in total."

Answered by AI

How many facilities are running this experiment?

"This trial has recruited participants from 45 different medical centres, such as South Texas Cardiovascular Consultants in San Antonio, HonorHealth in Scottsdale, and St. Michael's Hospital in Toronto."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
Mississippi
How old are they?
18 - 65
What site did they apply to?
Arizona Cardiovascular Research Center
Hightower Clinical
Emory University Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

My EF has dropped from 45 to 30. it was 20-25 before a mitral vale clip inserted in August 2023. I have been living with CHD since July 2004.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
SyncAV Post-Market Trial
2019. "SyncAV Post-Market Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04100148.
All > Congestive Heart Failure
~288 spots leftby Jun 2025
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