SyncAV Post-Market Trial (SyncAV)

December 16, 2025 updated by: Abbott Medical Devices
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The SyncAV Post-Market Trial is designed as a prospective, randomized, multi-center trial. The trial will require physicians to implant an Abbott CRT device and Abbott Quadripolar LV lead with any available right atrial and right ventricular leads. Sites will randomize subjects in a 1:1 ratio within 2 - 6 weeks post successful CRT implant: Arm 1 - SyncAV CRT programmed ON; Arm 2 - programmed fixed atrioventricular (AV) delay.

For those subjects randomized to SyncAV programmed ON, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF), at biventricular (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.

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.

Sites will collect data at baseline (before CRT implant), randomization, and at 3-month, 6-month, and 12-month visits. For subjects randomized to the SyncAV ON arm, sites will optimize the SyncAV feature again at 3 months and 6 months in the same manner as the randomization visit.

Study Type

Interventional

Enrollment (Actual)

1686

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8036
        • Universitätsklinik Graz
  • Belgium
      • Brussels, Belgium
        • Hôpital Erasme
  • Canada
      • Edmonton, Canada
        • Royal Alexandra Hospital
      • Montreal, Canada
        • CHUM
      • Québec, Canada, G1V 4G5
        • Institut de Cardiologie de Quebec (Hôpital Laval)
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2E8
        • St. Paul's Hospital
      • Victoria, British Columbia, Canada
        • Royal Jubilee Hospital
    • Montreal
      • Montreal, Montreal, Canada, H4J 1C5
        • Hopital Du Sacre-Coeur de Montreal
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • HSC, Eastern Health
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • QE II Health Sciences
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital
      • Kitchener, Ontario, Canada
        • St. Mary's General Hospital
      • Scarborough Village, Ontario, Canada, M1B 4Z8
        • Cardiac Arrhythmia Research Group Inc. (CARGI)
      • Toronto, Ontario, Canada, M5B 1WB
        • St. Michael's Hospital
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Institut de Cardiologie de Montreal (Montreal Heart Inst.)
      • Montreal, Quebec, Canada
        • McGill University Health Centre General Hospital
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • CHUS Fleurimont
  • China
    • Heping
      • Tianjin, Heping, China, 300041
        • Tianjin Chest Hospital
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital
  • Finland
      • Helsinki, Finland
        • Helsinki University Central Hospital (HYKS)
  • France
      • Rennes, France
        • CHRU Hopital de Pontchaillou
      • Saint-Priest-en-Jarez, France
        • St-Etienne CHU
    • Midi-Pyrenees
      • Toulouse, Midi-Pyrenees, France, 31059
        • CHU Rangueil Toulouse
    • Île-de-France Region
      • Créteil, Île-de-France Region, France, 94010
        • Hôpital Henri Mondor
      • Saint-Denis, Île-de-France Region, France, 97405
        • CHR de La Reunion - Site du CHFG
  • Germany
      • Bad Nauheim, Germany
        • Kerckhoff-Klinik gGmbH
    • Bad-wur
      • Heidelberg, Bad-wur, Germany
        • Klinikum der Ruprecht-Karls-Universität Heidelberg
    • Saxony
      • Dresden, Saxony, Germany
        • Herzzentrum Dresden GmbH Universitätsklinik
  • Hong Kong
      • Hong Kong, Hong Kong
        • The University of Hong Kong (Queen Mary Hospital)
  • India
      • Gurgaon, India
        • Medanta - The Medicity Hospital
      • New Delhi, India
        • Max Super Specialty Hospital
    • Andprad
      • Hyderabad, Andprad, India, 500082
        • Asian Institute of Gastroenterology (AIG) Hospital
    • Gujarat
      • Ahmedabad, Gujarat, India, 380060
        • Care Institute of Medical Sciences
    • Karnataka
      • Bangalore, Karnataka, India, 560076
        • Apollo Hospitals, Bangalore
      • Bangalore, Karnataka, India, 560099
        • Narayana Institute of Cardiac Sciences, Bommasandra
  • Italy
      • Avellino, Italy
        • Azienda Ospedaliera S. G. Moscati
    • Apulia
      • Bari, Apulia, Italy, 70125
        • Mater Dei Hospital
      • Carbonara, Apulia, Italy, 70131
        • Azienda Ospedaliera Di Venere
    • Calabria
      • Catanzaro, Calabria, Italy, 88100
        • Azienda Ospedaliera Universitaria MaterDomini
  • Japan
    • Chiba
      • Chiba, Chiba, Japan
        • Chiba University
    • Hyōgo
      • Nishinomiya, Hyōgo, Japan, 663-8501
        • Hyogo College of Medicine
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • St. Marianna University School of Medicine Hospital
    • Kanagwa
      • Sagamihara, Kanagwa, Japan, 252-0375
        • Kitasato University Hospital
  • Netherlands
    • Noord-h
      • Amsterdam, Noord-h, Netherlands, 1105 AZ
        • Amsterdam Academic Medical Centre (AMC)
  • Poland
      • Poznan, Poland
        • Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu
    • Lesrpld
      • Krakow, Lesrpld, Poland
        • Scanmed SA
  • Portugal
      • Lisbon, Portugal
        • Santa Maria Hospital
  • Puerto Rico
      • Ponce, Puerto Rico
        • Arrhythmia Group LLC
  • Russia
    • Siberia
      • Novosibirsk, Siberia, Russia
        • Meshalkin National Medical Research Center
  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • King Fahad Medical City
    • Mecca Region
      • Jeddah, Mecca Region, Saudi Arabia
        • King Fahad Armed Forces Hospital
    • Riyadh Region
      • Riyadh, Riyadh Region, Saudi Arabia, 12713
        • King Faisal Specialist Hospital (KFSH)
  • Serbia
      • Belgrade, Serbia
        • Clinical Center of Serbia - Pacemaker Center
  • South Korea
      • Daegu, South Korea
        • Keimyung University Dongsan Medical Center
      • Seoul, South Korea
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea
        • Asan Medical Centre
    • Sudogwn
      • Bucheon-si, Sudogwn, South Korea
        • Sejong Hospital
      • Daegu, Sudogwn, South Korea, 42601
        • Keimyung University Dongsan Medical Center
      • Seongnam, Sudogwn, South Korea, 463-707
        • Seoul National University Bundang Hospital
    • Sudogwon
      • Seoul, Sudogwon, South Korea, 135-710
        • Samsung Medical Center
  • Spain
      • Badajoz, Spain
        • Hospital Universitario Infanta Cristina
      • Barcelona, Spain
        • Hospital Clinic De Barcelona
      • Madrid, Spain
        • Fundación Jiménez Díaz
      • Madrid, Spain
        • Hospital Puerta de Hierro - Hospital Universitario
      • Málaga, Spain
        • HCU Virgen de la Victoria
      • Salamanca, Spain
        • Hospital Universitario de Salamanca
  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hospital, Solna
  • Taiwan
      • Taichung, Taiwan
        • Taichung Veterans General Hospital
  • Thailand
    • Central Thailand
      • Bangkok, Central Thailand, Thailand, 10400
        • Phramongkutklao Hospital
  • United Kingdom
      • Brighton, United Kingdom
        • The Royal Sussex County Hospital
    • Soeast
      • Southampton, Soeast, United Kingdom, SO16 6YD
        • Southampton University Hospital
    • South East England
      • Oxford, South East England, United Kingdom, OX3 9DU
        • John Radcliffe Hospital
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research, LLC.
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Arizona Cardiovascular Research Center
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth
    • California
      • Bakersfield, California, United States, 93309
        • Comprehensive Cardiovascular
      • Fresno, California, United States, 93720
        • Cardiovascular Consultants Heart Center
      • Los Angeles, California, United States, 90033-5313
        • USC University Hospital
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Colorado Heart & Vascular, P.C.
    • Florida
      • Gainesville, Florida, United States, 32610
        • Shands at the University of Florida
      • Hollywood, Florida, United States, 33328
        • Heart Rhythm Solutions
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30309
        • Piedmont Heart Institute
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Heart Center
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Sparrow Clinical Research Institute
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Hampshire
      • Manchester, New Hampshire, United States, 03102
        • Catholic Medical Center
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart & Lung Center
      • Haddon Heights, New Jersey, United States, 08035
        • Cardiovascular Associates of the Delaware Valley
      • Voorhees Township, New Jersey, United States, 08043
        • Lourdes Cardiology Services
    • New York
      • Brooklyn, New York, United States, 11215
        • New York Presbyterian Brooklyn Methodist Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Toledo, Ohio, United States, 43606
        • The Toledo Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Hightower Clinical
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Houston, Texas, United States, 77030
        • CHI St. Luke's Health Baylor College of Medicine Med. Ctr.
      • Houston, Texas, United States, 77094
        • Memorial Katy Cardiology Associates
      • San Antonio, Texas, United States, 78201
        • South Texas Cardiovascular Consultants
      • Shenandoah, Texas, United States, 77380
        • Heart Rhythm Associates
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SyncAV Arm
Treatment Arm
Device: 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.
Active Comparator: Fixed AV Delay Arm
Control Arm
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in left ventricular end systolic volume (LVESV) between baseline and 12 months
Time Frame: 12 months following trial randomization
Reduction of LVESV as a continuous variable from baseline to 12 months compared between subjects in the SyncAV and fixed AV delay arms.
12 months following trial randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of CRT Responders at 12 months
Time Frame: 12 months following trial randomization
Percentage of subjects classified as CRT responders after 12 months of follow-up compared between subjects in the SyncAV and fixed AV delay arms, as measured by LVESV reduction of at least 15% compared to baseline.
12 months following trial randomization
Reduction in LVESV in female subjects between baseline and 12 months
Time Frame: 12 months following trial randomization
Reduction of LVESV as a continuous variable from baseline to 12 months compared between female subjects in the SyncAV and fixed AV delay arms.
12 months following trial randomization
Percentage of female subjects classified as CRT Responders at 12 months
Time Frame: 12 months following trial randomization
Percentage of female subjects classified as CRT responders after 12 months of follow-up compared between female subjects in the SyncAV and fixed AV delay arms, as measured by LVESV reduction of at least 15% compared to baseline.
12 months following trial randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Niraj Varma, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2019

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

September 20, 2019

First Submitted That Met QC Criteria

September 20, 2019

First Posted (Actual)

September 24, 2019

Study Record Updates

Last Update Posted (Estimated)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT-CIP-10299

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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