SyncAV Post-Market Trial

NCT04100148 | Active Not Recruiting FDA Device

• 1 other identifier: ABT-CIP-10299
• Study Type: interventional
• Target: 1,686
• Locations: 24 countries
• Sites: 103

Brief 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.

Conditions

Congestive Heart Failure

Keywords

SyncAV feature; CRT optimization; CRT non-responders; ECG optimization; Cardiac remodeling; CRT with SyncAV

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months following trial randomization

Secondary Outcomes (3)

• Percentage of CRT Responders at 12 months

  12 months following trial randomization

• Reduction in LVESV in female subjects between baseline and 12 months

  12 months following trial randomization

• Percentage of female subjects classified as CRT Responders at 12 months

  12 months following trial randomization

Study Arms (2)

SyncAV Arm

EXPERIMENTAL

Treatment Arm

Device: SyncAV programmed ON

Fixed AV Delay Arm

ACTIVE COMPARATOR

Control Arm

Device: Fixed AV delay

Interventions

SyncAV programmed ON DEVICE

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.

SyncAV Arm

Fixed AV delay DEVICE

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.

Fixed AV Delay Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (104)

Heart Center Research, LLC.

Huntsville, Alabama, 35801, United States

Location

Arizona Cardiovascular Research Center

Phoenix, Arizona, 85016, United States

Location

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

Comprehensive Cardiovascular

Bakersfield, California, 93309, United States

Location

Cardiovascular Consultants Heart Center

Fresno, California, 93720, United States

Location

USC University Hospital

Los Angeles, California, 90033-5313, United States

Location

Colorado Heart & Vascular, P.C.

Lakewood, Colorado, 80228, United States

Location

Shands at the University of Florida

Gainesville, Florida, 32610, United States

Location

Heart Rhythm Solutions

Hollywood, Florida, 33328, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Sparrow Clinical Research Institute

Lansing, Michigan, 48912, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Deborah Heart & Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Cardiovascular Associates of the Delaware Valley

Haddon Heights, New Jersey, 08035, United States

Location

Lourdes Cardiology Services

Voorhees Township, New Jersey, 08043, United States

Location

New York Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Hightower Clinical

Oklahoma City, Oklahoma, 73102, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

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

Houston, Texas, 77030, United States

Location

Memorial Katy Cardiology Associates

Houston, Texas, 77094, United States

Location

South Texas Cardiovascular Consultants

San Antonio, Texas, 78201, United States

Location

Heart Rhythm Associates

Shenandoah, Texas, 77380, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Universitätsklinik Graz

Graz, Styria, 8036, Austria

Location

Hopital Erasme

Brussels, Belgium

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 2E8, Canada

Location

Royal Jubilee Hospital

Victoria, British Columbia, Canada

Location

Hopital du Sacre-Coeur de Montreal

Montreal, Montreal, H4J 1C5, Canada

Location

HSC, Eastern Health

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

Location

QE II Health Sciences

Halifax, Nova Scotia, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

St. Mary's General Hospital

Kitchener, Ontario, Canada

Location

Cardiac Arrhythmia Research Group Inc. (CARGI)

Scarborough Village, Ontario, M1B 4Z8, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1WB, Canada

Location

Institut de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, Quebec, H1T 1C8, Canada

Location

McGill University Health Centre General Hospital

Montreal, Quebec, Canada

Location

CHUS Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Royal Alexandra Hospital

Edmonton, Canada

Location

CHUM

Montreal, Canada

Location

Institut de Cardiologie de Quebec (Hôpital Laval)

Québec, G1V 4G5, Canada

Location

Tianjin Chest Hospital

Tianjin, Heping, 300041, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

Location

Helsinki University Central Hospital (HYKS)

Helsinki, Finland

Location

CHU Rangueil Toulouse

Toulouse, Midi-Pyrenees, 31059, France

Location

CHRU Hopital de Pontchaillou

Rennes, France

Location

St-Etienne CHU

Saint-Priest-en-Jarez, France

Location

Hopital Henri Mondor

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

Location

CHR de La Reunion - Site du CHFG

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

Location

Klinikum der Ruprecht-Karls-Universität Heidelberg

Heidelberg, Bad-wur, Germany

Location

Herzzentrum Dresden GmbH Universitätsklinik

Dresden, Saxony, Germany

Location

Kerckhoff-Klinik gGmbH

Bad Nauheim, Germany

Location

The University of Hong Kong (Queen Mary Hospital)

Hong Kong, Hong Kong

Location

Asian Institute of Gastroenterology (AIG) Hospital

Hyderabad, Andprad, 500082, India

Location

Care Institute of Medical Sciences

Ahmedabad, Gujarat, 380060, India

Location

Apollo Hospitals, Bangalore

Bangalore, Karnataka, 560076, India

Location

Narayana Institute of Cardiac Sciences, Bommasandra

Bangalore, Karnataka, 560099, India

Location

Medanta - The Medicity Hospital

Gūrgaon, India

Location

Max Super Specialty Hospital

New Delhi, India

Location

Mater Dei Hospital

Bari, Apulia, 70125, Italy

Location

Azienda Ospedaliera Di Venere

Carbonara, Apulia, 70131, Italy

Location

Azienda Ospedaliera Universitaria MaterDomini

Catanzaro, Calabria, 88100, Italy

Location

Azienda Ospedaliera S. G. Moscati

Avellino, Italy

Location

Chiba University

Chiba, Chiba, Japan

Location

Hyogo College of Medicine

Nishinomiya, Hyōgo, 663-8501, Japan

Location

St. Marianna University School of Medicine Hospital

Kawasaki, Kanagawa, 216-8511, Japan

Location

Kitasato University Hospital

Sagamihara, Kanagwa, 252-0375, Japan

Location

Amsterdam Academic Medical Centre (AMC)

Amsterdam, Noord-h, 1105 AZ, Netherlands

Location

Scanmed SA

Krakow, Lesrpld, Poland

Location

Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu

Poznan, Poland

Location

Santa Maria Hospital

Lisbon, Portugal

Location

Arrhythmia Group LLC

Ponce, Puerto Rico

Location

Meshalkin National Medical Research Center

Novosibirsk, Siberia, Russia

Location

King Fahad Armed Forces Hospital

Jeddah, Mecca Region, Saudi Arabia

Location

King Faisal Specialist Hospital (KFSH)

Riyadh, Riyadh Region, 12713, Saudi Arabia

Location

King Fahad Medical City

Riyadh, Saudi Arabia

Location

Clinical Center of Serbia - Pacemaker Center

Belgrade, Serbia

Location

Sejong Hospital

Bucheon-si, Sudogwn, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, Sudogwn, 42601, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, Sudogwn, 463-707, South Korea

Location

Samsung Medical Center

Seoul, Sudogwon, 135-710, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Asan Medical Centre

Seoul, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

Hospital Universitario Infanta Cristina

Badajoz, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Fundación Jiménez Díaz

Madrid, Spain

Location

Hospital Puerta de Hierro - Hospital Universitario

Madrid, Spain

Location

HCU Virgen de la Victoria

Málaga, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Spain

Location

Karolinska University Hospital, Solna

Stockholm, Sweden

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

Phramongkutklao Hospital

Bangkok, Central Thailand, 10400, Thailand

Location

Southampton University Hospital

Southampton, Soeast, SO16 6YD, United Kingdom

Location

John Radcliffe Hospital

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

Location

The Royal Sussex County Hospital

Brighton, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Niraj Varma, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 24, 2019
• Study Start: October 3, 2019
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (16); AU (1); PR (1); IN (6); IT (4); PT (1); PL (2); HK (1); SA (3); KR (7); TH (1); GB (3); BE (1); FI (1); JP (4); NL (1); SE (1); FR (5); ES (6); RU (1); CN (3); DE (3); TW (1); US (30)