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Heart device upgrade: could SyncAV pacing improve heart function?

NCT ID NCT04100148

Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial studies whether a special pacing feature called SyncAV, used in heart devices, can improve heart function in people with congestive heart failure. About 1,686 participants will get a new or upgraded heart device and be randomly assigned to have SyncAV on or a standard fixed delay. The main goal is to see if SyncAV leads to better heart remodeling after 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SyncAV pacing feature (a device-based intervention)
What this could lead to
If successful, this could show that SyncAV pacing improves heart function better than standard pacing for people with heart failure.
What could go wrong
This is a post-market study, not a new drug, so the benefit may be modest. The results may not apply to all heart failure patients, and device programming can be complex.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

1,686 people

The number who actually took part.

Started

Oct 2019

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

congestive heart failure heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congestive heart failure

Contacts and locations

Locations

  • Amsterdam Academic Medical Centre (AMC)

    Amsterdam, Noord-h, 1105 AZ, Netherlands

  • Apollo Hospitals, Bangalore

    Bangalore, Karnataka, 560076, India

  • Arizona Cardiovascular Research Center

    Phoenix, Arizona, 85016, United States

  • Arrhythmia Group LLC

    Ponce, Puerto Rico

  • Asan Medical Centre

    Seoul, South Korea

  • Asian Institute of Gastroenterology (AIG) Hospital

    Hyderabad, Andprad, 500082, India

  • Azienda Ospedaliera Di Venere

    Carbonara di Bari, Apulia, 70131, Italy

  • Azienda Ospedaliera S. G. Moscati

    Avellino, Italy

  • Azienda Ospedaliera Universitaria MaterDomini

    Catanzaro, Calabria, 88100, Italy

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

  • CHI St. Luke's Health Baylor College of Medicine Med. Ctr.

    Houston, Texas, 77030, United States

  • CHR de La Reunion - Site du CHFG

    Saint-Denis, Île-de-France Region, 97405, France

  • CHRU Hopital de Pontchaillou

    Rennes, France

  • CHU Rangueil Toulouse

    Toulouse, Midi-Pyrenees, 31059, France

  • CHUM

    Montreal, Canada

  • CHUS Fleurimont

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Cardiac Arrhythmia Research Group Inc. (CARGI)

    Scarborough Village, Ontario, M1B 4Z8, Canada

  • Cardiovascular Associates of the Delaware Valley

    Haddon Heights, New Jersey, 08035, United States

  • Cardiovascular Consultants Heart Center

    Fresno, California, 93720, United States

  • Care Institute of Medical Sciences

    Ahmedabad, Gujarat, 380060, India

  • Catholic Medical Center

    Manchester, New Hampshire, 03102, United States

  • Chiba University

    Chiba, Chiba, Japan

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Clinical Center of Serbia - Pacemaker Center

    Belgrade, Serbia

  • Colorado Heart & Vascular, P.C.

    Lakewood, Colorado, 80228, United States

  • Comprehensive Cardiovascular

    Bakersfield, California, 93309, United States

  • Deborah Heart & Lung Center

    Browns Mills, New Jersey, 08015, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9, Canada

  • Fundación Jiménez Díaz

    Madrid, Spain

  • HCU Virgen de la Victoria

    Málaga, Spain

  • HSC, Eastern Health

    St. John's, Newfoundland and Labrador, A1B 3V6, Canada

  • Heart Center Research, LLC.

    Huntsville, Alabama, 35801, United States

  • Heart Rhythm Associates

    Shenandoah, Texas, 77380, United States

  • Heart Rhythm Solutions

    Hollywood, Florida, 33328, United States

  • Helsinki University Central Hospital (HYKS)

    Helsinki, Finland

  • Herzzentrum Dresden GmbH Universitätsklinik

    Dresden, Saxony, Germany

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73102, United States

  • HonorHealth

    Scottsdale, Arizona, 85258, United States

  • Hopital Erasme

    Brussels, Belgium

  • Hopital Henri Mondor

    Créteil, Île-de-France Region, 94010, France

  • Hopital du Sacre-Coeur de Montreal

    Montreal, Montreal, H4J 1C5, Canada

  • Hospital Clínic de Barcelona

    Barcelona, Spain

  • Hospital Puerta de Hierro - Hospital Universitario

    Madrid, Spain

  • Hospital Universitario Infanta Cristina

    Badajoz, Spain

  • Hospital Universitario de Salamanca

    Salamanca, Spain

  • Hyogo College of Medicine

    Nishinomiya, Hyōgo, 663-8501, Japan

  • Institut de Cardiologie de Montreal (Montreal Heart Inst.)

    Montreal, Quebec, H1T 1C8, Canada

  • Institut de Cardiologie de Quebec (Hôpital Laval)

    Québec, G1V 4G5, Canada

  • Iowa Heart Center

    West Des Moines, Iowa, 50266, United States

  • John Radcliffe Hospital

    Oxford, South East England, OX3 9DU, United Kingdom

  • Karolinska University Hospital, Solna

    Stockholm, Sweden

  • Keimyung University Dongsan Medical Center

    Daegu, Sudogwn, 42601, South Korea

  • Keimyung University Dongsan Medical Center

    Daegu, South Korea

  • Kerckhoff-Klinik gGmbH

    Bad Nauheim, Germany

  • King Fahad Armed Forces Hospital

    Jeddah, Mecca Region, Saudi Arabia

  • King Fahad Medical City

    Riyadh, Saudi Arabia

  • King Faisal Specialist Hospital (KFSH)

    Riyadh, Riyadh Region, 12713, Saudi Arabia

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7, Canada

  • Kitasato University Hospital

    Sagamihara, Kanagwa, 252-0375, Japan

  • Klinikum der Ruprecht-Karls-Universität Heidelberg

    Heidelberg, Bad-wur, Germany

  • Lourdes Cardiology Services

    Voorhees Township, New Jersey, 08043, United States

  • Mater Dei Hospital

    Bari, Apulia, 70125, Italy

  • Max Super Specialty Hospital

    New Delhi, India

  • McGill University Health Centre General Hospital

    Montreal, Quebec, Canada

  • Medanta - The Medicity Hospital

    Gurgaon, India

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Memorial Katy Cardiology Associates

    Houston, Texas, 77094, United States

  • Meshalkin National Medical Research Center

    Novosibirsk, Siberia, Russia

  • Narayana Institute of Cardiac Sciences, Bommasandra

    Bangalore, Karnataka, 560099, India

  • New York Presbyterian Brooklyn Methodist Hospital

    Brooklyn, New York, 11215, United States

  • Phramongkutklao Hospital

    Bangkok, Central Thailand, 10400, Thailand

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309, United States

  • QE II Health Sciences

    Halifax, Nova Scotia, Canada

  • Royal Alexandra Hospital

    Edmonton, Canada

  • Royal Jubilee Hospital

    Victoria, British Columbia, Canada

  • Samsung Medical Center

    Seoul, Sudogwon, 135-710, South Korea

  • Santa Maria Hospital

    Lisbon, Portugal

  • Scanmed SA

    Krakow, Lesrpld, Poland

  • Sejong Hospital

    Bucheon-si, Sudogwn, South Korea

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • Seoul National University Bundang Hospital

    Seongnam, Sudogwn, 463-707, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

  • Shands at the University of Florida

    Gainesville, Florida, 32610, United States

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310016, China

  • South Texas Cardiovascular Consultants

    San Antonio, Texas, 78201, United States

  • Southampton University Hospital

    Southampton, Soeast, SO16 6YD, United Kingdom

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912, United States

  • St-Etienne CHU

    Saint-Priest-en-Jarez, France

  • St. Marianna University School of Medicine Hospital

    Kawasaki, Kanagawa, 216-8511, Japan

  • St. Mary's General Hospital

    Kitchener, Ontario, Canada

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1WB, Canada

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 2E8, Canada

  • Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu

    Poznan, Poland

  • Taichung Veterans General Hospital

    Taichung, Taiwan

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061, China

  • The Royal Sussex County Hospital

    Brighton, United Kingdom

  • The Toledo Hospital

    Toledo, Ohio, 43606, United States

  • The University of Hong Kong (Queen Mary Hospital)

    Hong Kong, Hong Kong

  • Tianjin Chest Hospital

    Tianjin, Heping, 300041, China

  • USC University Hospital

    Los Angeles, California, 90033-5313, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • Universitätsklinik Graz

    Graz, Styria, 8036, Austria

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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Other studies related to the condition(s) this trial covers.