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Clinical Trials in the UK / NCT04100148
Active, not recruiting Not applicable

SyncAV Post-Market Trial

NCT04100148 · tracked via the Priya Life Science UK tracker
Sponsor
Abbott Medical Devices
Phase
Not applicable
Started
2019-10-03
Last updated
2025-12-18

Condition(s) studied

Congestive Heart Failure

Investigational drug(s) / intervention(s)

SyncAV programmed ONFixed AV delay

SyncAV programmed ON: For those subjects randomized to SyncAV programmed ON, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF), at BiV pacing nominal settings, with various SyncAV programmed offsets, and at LV first 30 ms, RV first 30 ms and LV-only pacing with optimal SyncAV offsets. The site will then program the subject's device using the SyncAV offset that provided the narrowest QRS duration.

Fixed AV delay: For those subjects randomized to the fixed AV delay arm, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF) and at BiV pacing nominal settings. Sites will then program the subject's device using BiV pacing nominal settings.

Study summary

The SyncAV Post-Market Trial is a prospective, randomized, multi-center trial performed to determine if cardiac resynchronization therapy (CRT) devices programmed with SyncAV ON improve long-term CRT response compared to devices programmed with conventional CRT through evaluation of changes in left ventricular (LV) reverse remodeling.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. 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: 1. Mild to severe heart failure despite optimal medical therapy for at least 3 months prior to signing consent. Optimal medical therapy is defined as maximal tolerated dose of beta-blockers and a therapeutic dose of angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, or aldosterone antagonist 2. LVEF ≤ 35% based on a prior standard of care echocardiogram 3. Left bundle branch block (LBBB) as documented on an ECG. Criteria for complete LBBB should include, i. QRS duration ≥ 120 ms ii. QS or rS pattern in leads V1 iii. mid-QRS notching or slurring in leads I, aVL, V5, and V6 iv. Absence of Q-wave in leads V5 and V6 d. Intact AV conduction (PR interval ≤ 280 ms on surface ECG) 2. At least 18 years old, or of legal age and willing and capable to give informed consent specific to each country and national laws 3. Willing and able to comply with the prescribed follow-up tests and schedule of evaluations Exclusion Criteria: 1. Recent myocardial infarction or unstable angina within 40 days prior to signing consent 2. Recent cardiac revascularization (angioplasty, stent or bypass graft) in the 4 weeks prior to signing consent or planned within 3 months following consent 3. Cerebrovascular accident or transient ischemic attack in the 3 months prior to signing consent 4. Any other therapeutic cardiovascular procedure (transcatheter aortic valve replacement, MitraClip, cardiac surgery, left atrial appendage closure, patent foramen ovale closure, or any ablation procedures) in the 3 months prior to signing consent 5. Permanent or persistent AF at the time of signing consent 6. Paroxysmal AF with at least one cardioversion within 60 days prior to signing consent 7. Prior CRT device implant 8. Prior His Bundle pacing implant or plan to have His Bundle pacing implant 9. Pregnant or breastfeeding at the time of signing consent 10. Incapacitated or unable to read or write 11. Undergone cardiac transplantation or have a classification of Status 1 for cardiac transplantation or consideration for transplantation during the study follow-up period 12. Life expectancy \< 12 months due to any condition 13. Unavailable for at least 12 months of follow-up visits 14. Enrolled in or intend to participate in a clinical drug and/or device study during this clinical trial which could confound the results of this trial as determined by Abbott

Primary outcome measure(s)

Trial sites (104)

FacilityCityRegionStatus
Heart Center Research, LLC. Huntsville Alabama
Arizona Cardiovascular Research Center Phoenix Arizona
HonorHealth Scottsdale Arizona
Comprehensive Cardiovascular Bakersfield California
Cardiovascular Consultants Heart Center Fresno California
USC University Hospital Los Angeles California
Colorado Heart & Vascular, P.C. Lakewood Colorado
Shands at the University of Florida Gainesville Florida
Heart Rhythm Solutions Hollywood Florida
Piedmont Heart Institute Atlanta Georgia
Emory University Hospital Atlanta Georgia
Iowa Heart Center West Des Moines Iowa
Baptist Health Lexington Lexington Kentucky
Sparrow Clinical Research Institute Lansing Michigan
Washington University School of Medicine St Louis Missouri
Catholic Medical Center Manchester New Hampshire
Deborah Heart & Lung Center Browns Mills New Jersey
Cardiovascular Associates of the Delaware Valley Haddon Heights New Jersey
Lourdes Cardiology Services Voorhees Township New Jersey
New York Presbyterian Brooklyn Methodist Hospital Brooklyn New York
Cleveland Clinic Foundation Cleveland Ohio
The Toledo Hospital Toledo Ohio
Hightower Clinical Oklahoma City Oklahoma
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
Medical University of South Carolina Charleston South Carolina
CHI St. Luke's Health Baylor College of Medicine Med. Ctr. Houston Texas
Memorial Katy Cardiology Associates Houston Texas
South Texas Cardiovascular Consultants San Antonio Texas
Heart Rhythm Associates Shenandoah Texas
Sentara Norfolk General Hospital Norfolk Virginia
Universitätsklinik Graz Graz Styria
Hopital Erasme Brussels Belgium
Foothills Medical Centre Calgary Alberta
St. Paul's Hospital Vancouver British Columbia
Royal Jubilee Hospital Victoria British Columbia
Hopital du Sacre-Coeur de Montreal Montreal Montreal
HSC, Eastern Health St. John's Newfoundland and Labrador
QE II Health Sciences Halifax Nova Scotia
Kingston General Hospital Kingston Ontario
St. Mary's General Hospital Kitchener Ontario

+ 64 more sites — see the full list on the official registry below.

More Abbott Medical Devices trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04100148 on ClinicalTrials.gov ↗ ← All trials in the UK