Congestive Heart FailureSyncAVNCT04100148
SyncAV Post-Market Trial
A study testing SyncAV programmed ON and Fixed AV delay in people with Congestive Heart Failure, run by Abbott Medical Devices at 104 sites in 25 countries.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- SyncAV programmed ON and Fixed AV delay
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,686 participants
- Where
- 104 sitesin 25 countries
- Study dates
- 3 Oct 2019to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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
- LVEF ≤ 35% based on a prior standard of care echocardiogram
- Left bundle branch block (LBBB) as documented on an ECG. Criteria for complete LBBB should include,
- 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)
- At least 18 years old, or of legal age and willing and capable to give informed consent specific to each country and national laws
- Willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Who cannot join
- Recent myocardial infarction or unstable angina within 40 days prior to signing consent
- Recent cardiac revascularization (angioplasty, stent or bypass graft) in the 4 weeks prior to signing consent or planned within 3 months following consent
- Cerebrovascular accident or transient ischemic attack in the 3 months prior to signing consent
- 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
- Permanent or persistent AF at the time of signing consent
- Paroxysmal AF with at least one cardioversion within 60 days prior to signing consent
Show all 14Show fewer
- Prior CRT device implant
- Prior His Bundle pacing implant or plan to have His Bundle pacing implant
- Pregnant or breastfeeding at the time of signing consent
- Incapacitated or unable to read or write
- Undergone cardiac transplantation or have a classification of Status 1 for cardiac transplantation or consideration for transplantation during the study follow-up period
- Life expectancy < 12 months due to any condition
- Unavailable for at least 12 months of follow-up visits
- 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
Trial locations and contacts
104 sites in 25 countries.
104 sites in 25 countries
United States30 sites
Piedmont Heart Institute
Atlanta, Georgia, 30309
Emory University Hospital
Atlanta, Georgia, 30322
Comprehensive Cardiovascular
Bakersfield, California, 93309
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Deborah Heart & Lung Center
Browns Mills, New Jersey, 08015
Medical University of South Carolina
Charleston, South Carolina, 29425
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Cardiovascular Consultants Heart Center
Fresno, California, 93720
Shands at the University of Florida
Gainesville, Florida, 32610
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, 08035
Heart Rhythm Solutions
Hollywood, Florida, 33328
CHI St. Luke's Health Baylor College of Medicine Med. Ctr.
Houston, Texas, 77030
Memorial Katy Cardiology Associates
Houston, Texas, 77094
Heart Center Research, LLC.
Huntsville, Alabama, 35801
Colorado Heart & Vascular, P.C.
Lakewood, Colorado, 80228
Sparrow Clinical Research Institute
Lansing, Michigan, 48912
Baptist Health Lexington
Lexington, Kentucky, 40503
USC University Hospital
Los Angeles, California, 90033-5313
Catholic Medical Center
Manchester, New Hampshire, 03102
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Hightower Clinical
Oklahoma City, Oklahoma, 73102
Arizona Cardiovascular Research Center
Phoenix, Arizona, 85016
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
South Texas Cardiovascular Consultants
San Antonio, Texas, 78201
HonorHealth
Scottsdale, Arizona, 85258
Heart Rhythm Associates
Shenandoah, Texas, 77380
Washington University School of Medicine
St Louis, Missouri, 63110
The Toledo Hospital
Toledo, Ohio, 43606
Lourdes Cardiology Services
Voorhees Township, New Jersey, 08043
Iowa Heart Center
West Des Moines, Iowa, 50266
Canada16 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Royal Alexandra Hospital
Edmonton
QE II Health Sciences
Halifax, Nova Scotia
Kingston General Hospital
Kingston, Ontario, K7L 2V7
St. Mary's General Hospital
Kitchener, Ontario
Hopital du Sacre-Coeur de Montreal
Montreal, Montreal, H4J 1C5
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec, H1T 1C8
McGill University Health Centre General Hospital
Montreal, Quebec
CHUM
Montreal
Institut de Cardiologie de Quebec (Hôpital Laval)
Québec, G1V 4G5
Cardiac Arrhythmia Research Group Inc. (CARGI)
Scarborough Village, Ontario, M1B 4Z8
CHUS Fleurimont
Sherbrooke, Quebec, J1H 5N4
HSC, Eastern Health
St. John's, Newfoundland and Labrador, A1B 3V6
St. Michael's Hospital
Toronto, Ontario, M5B 1WB
St. Paul's Hospital
Vancouver, British Columbia, V6Z 2E8
Royal Jubilee Hospital
Victoria, British Columbia
South Korea7 sites
Sejong Hospital
Bucheon-si, Sudogwn
Keimyung University Dongsan Medical Center
Daegu, Sudogwn, 42601
Keimyung University Dongsan Medical Center
Daegu
Seoul National University Bundang Hospital
Seongnam, Sudogwn, 463-707
Samsung Medical Center
Seoul, Sudogwon, 135-710
Asan Medical Centre
Seoul
Severance Hospital, Yonsei University Health System
Seoul
India6 sites
Care Institute of Medical Sciences
Ahmedabad, Gujarat, 380060
Apollo Hospitals, Bangalore
Bangalore, Karnataka, 560076
Narayana Institute of Cardiac Sciences, Bommasandra
Bangalore, Karnataka, 560099
Medanta - The Medicity Hospital
Gūrgaon
Asian Institute of Gastroenterology (AIG) Hospital
Hyderabad, Andprad, 500082
Max Super Specialty Hospital
New Delhi
Spain6 sites
Hospital Universitario Infanta Cristina
Badajoz
Hospital Clínic de Barcelona
Barcelona
Fundación Jiménez Díaz
Madrid
Hospital Puerta de Hierro - Hospital Universitario
Madrid
HCU Virgen de la Victoria
Málaga
Hospital Universitario de Salamanca
Salamanca
France5 sites
Hopital Henri Mondor
Créteil, Île-de-France Region, 94010
CHRU Hopital de Pontchaillou
Rennes
CHR de La Reunion - Site du CHFG
Saint-Denis, Île-de-France Region, 97405
St-Etienne CHU
Saint-Priest-en-Jarez
CHU Rangueil Toulouse
Toulouse, Midi-Pyrenees, 31059
Italy4 sites
Azienda Ospedaliera S. G. Moscati
Avellino
Mater Dei Hospital
Bari, Apulia, 70125
Azienda Ospedaliera Di Venere
Carbonara di Bari, Apulia, 70131
Azienda Ospedaliera Universitaria MaterDomini
Catanzaro, Calabria, 88100
Japan4 sites
Chiba University
Chiba, Chiba
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, 216-8511
Hyogo College of Medicine
Nishinomiya, Hyōgo, 663-8501
Kitasato University Hospital
Sagamihara, Kanagwa, 252-0375
China3 sites
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016
Tianjin Chest Hospital
Tianjin, Heping, 300041
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Germany3 sites
Kerckhoff-Klinik gGmbH
Bad Nauheim
Herzzentrum Dresden GmbH Universitätsklinik
Dresden, Saxony
Klinikum der Ruprecht-Karls-Universität Heidelberg
Heidelberg, Bad-wur
Saudi Arabia3 sites
King Fahad Armed Forces Hospital
Jeddah, Mecca Region
King Faisal Specialist Hospital (KFSH)
Riyadh, Riyadh Region, 12713
King Fahad Medical City
Riyadh
United Kingdom3 sites
The Royal Sussex County Hospital
Brighton
John Radcliffe Hospital
Oxford, South East England, OX3 9DU
Southampton University Hospital
Southampton, Soeast, SO16 6YD
Poland2 sites
Scanmed SA
Krakow, Lesrpld
Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu
Poznan
Netherlands1 site
Amsterdam Academic Medical Centre (AMC)
Amsterdam, Noord-h, 1105 AZ
About this study
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.
Read the 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.
- Conditions
- Congestive Heart Failure
- Being tested
- SyncAV programmed ON, Fixed AV delay
- Keywords
- SyncAV feature, CRT optimization, CRT non-responders, ECG optimization, Cardiac remodeling, CRT with SyncAV
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyncAV programmed ONDevice
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 delayDevice
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 group | Role | What they receive |
|---|---|---|
| SyncAV Arm | Experimental | Treatment Arm Receives: Device: SyncAV programmed ON |
| Fixed AV Delay Arm | Active comparator | Control Arm Receives: Device: Fixed AV delay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in left ventricular end systolic volume (LVESV) between baseline and 12 months
Reduction of LVESV as a continuous variable from baseline to 12 months compared between subjects in the SyncAV and fixed AV delay arms.
Measured: 12 months following trial randomization
Secondary outcomes (3)
Percentage of CRT Responders at 12 months
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.
Measured: 12 months following trial randomization
Reduction in LVESV in female subjects between baseline and 12 months
Reduction of LVESV as a continuous variable from baseline to 12 months compared between female subjects in the SyncAV and fixed AV delay arms.
Measured: 12 months following trial randomization
Percentage of female subjects classified as CRT Responders at 12 months
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.
Measured: 12 months following trial randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start3 Oct 2019
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,686 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Niraj Varma, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100148
- Sponsor's protocol ID
- ABT-CIP-10299
- Acronym
- SyncAV
- Status last verified
- Dec 2025
- First submitted
- 20 Sep 2019
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SyncAV Post-Market Trial
- ClinicalTrials.gov ID
- NCT04100148
- Acronym / sponsor ID
- SyncAV / ABT-CIP-10299
- Conditions
- Congestive Heart Failure
- Keywords
- SyncAV feature, CRT optimization, CRT non-responders, ECG optimization, Cardiac remodeling, CRT with SyncAV
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,686 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SyncAV Arm | Experimental | Device: SyncAV programmed ONTreatment Arm |
| Fixed AV Delay Arm | Active comparator | Device: Fixed AV delayControl Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- At least 18 years old, or of legal age and willing and capable to give informed consent specific to each country and national laws
- Willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Key exclusion criteria (14 listed)
- Recent myocardial infarction or unstable angina within 40 days prior to signing consent
- Recent cardiac revascularization (angioplasty, stent or bypass graft) in the 4 weeks prior to signing consent or planned within 3 months following consent
- Cerebrovascular accident or transient ischemic attack in the 3 months prior to signing consent
- 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
- Permanent or persistent AF at the time of signing consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SyncAV programmed ONFor 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. | Device | SyncAV Arm |
| Fixed AV delayFor 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. | Device | Fixed AV Delay Arm |
Primary outcome
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.
3 secondary outcomes
Percentage of CRT Responders at 12 months
Time frame: 12 months following trial randomization
Reduction in LVESV in female subjects between baseline and 12 months
Time frame: 12 months following trial randomization
Percentage of female subjects classified as CRT Responders at 12 months
Time frame: 12 months following trial randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niraj Varma, MD principal investigator
The Cleveland Clinic
104 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SyncAV programmed ON and Fixed AV delay in people with Congestive Heart Failure, run by Abbott Medical Devices at 104 sites in 25 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 104 sites in United States, Canada, South Korea, India, Spain and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in left ventricular end systolic volume (LVESV) between baseline and 12 months (time frame: 12 months following trial randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.