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ACTIVE NOT RECRUITING
NCT04100148
NA

SyncAV Post-Market Trial

Sponsor: Abbott Medical Devices

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1686

Start Date

2019-10-03

Completion Date

2026-06-30

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

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.

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.

Locations (104)

Heart Center Research, LLC.

Huntsville, Alabama, United States

Arizona Cardiovascular Research Center

Phoenix, Arizona, United States

HonorHealth

Scottsdale, Arizona, United States

Comprehensive Cardiovascular

Bakersfield, California, United States

Cardiovascular Consultants Heart Center

Fresno, California, United States

USC University Hospital

Los Angeles, California, United States

Colorado Heart & Vascular, P.C.

Lakewood, Colorado, United States

Shands at the University of Florida

Gainesville, Florida, United States

Heart Rhythm Solutions

Hollywood, Florida, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

Iowa Heart Center

West Des Moines, Iowa, United States

Baptist Health Lexington

Lexington, Kentucky, United States

Sparrow Clinical Research Institute

Lansing, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Catholic Medical Center

Manchester, New Hampshire, United States

Deborah Heart & Lung Center

Browns Mills, New Jersey, United States

Cardiovascular Associates of the Delaware Valley

Haddon Heights, New Jersey, United States

Lourdes Cardiology Services

Voorhees Township, New Jersey, United States

New York Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

The Toledo Hospital

Toledo, Ohio, United States

Hightower Clinical

Oklahoma City, Oklahoma, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

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

Houston, Texas, United States

Memorial Katy Cardiology Associates

Houston, Texas, United States

South Texas Cardiovascular Consultants

San Antonio, Texas, United States

Heart Rhythm Associates

Shenandoah, Texas, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Universitätsklinik Graz

Graz, Styria, Austria

Hopital Erasme

Brussels, Belgium

Foothills Medical Centre

Calgary, Alberta, Canada

St. Paul's Hospital

Vancouver, British Columbia, Canada

Royal Jubilee Hospital

Victoria, British Columbia, Canada

Hopital du Sacre-Coeur de Montreal

Montreal, Montreal, Canada

HSC, Eastern Health

St. John's, Newfoundland and Labrador, Canada

QE II Health Sciences

Halifax, Nova Scotia, Canada

Kingston General Hospital

Kingston, Ontario, Canada

St. Mary's General Hospital

Kitchener, Ontario, Canada

Cardiac Arrhythmia Research Group Inc. (CARGI)

Scarborough Village, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Institut de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, Quebec, Canada

McGill University Health Centre General Hospital

Montreal, Quebec, Canada

CHUS Fleurimont

Sherbrooke, Quebec, Canada

Royal Alexandra Hospital

Edmonton, Canada

CHUM

Montreal, Canada

Institut de Cardiologie de Quebec (Hôpital Laval)

Québec, Canada

Tianjin Chest Hospital

Tianjin, Heping, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Helsinki University Central Hospital (HYKS)

Helsinki, Finland

CHU Rangueil Toulouse

Toulouse, Midi-Pyrenees, France

CHRU Hopital de Pontchaillou

Rennes, France

St-Etienne CHU

Saint-Priest-en-Jarez, France

Hopital Henri Mondor

Créteil, Île-de-France Region, France

CHR de La Reunion - Site du CHFG

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

Klinikum der Ruprecht-Karls-Universität Heidelberg

Heidelberg, Bad-wur, Germany

Herzzentrum Dresden GmbH Universitätsklinik

Dresden, Saxony, Germany

Kerckhoff-Klinik gGmbH

Bad Nauheim, Germany

The University of Hong Kong (Queen Mary Hospital)

Hong Kong, Hong Kong

Asian Institute of Gastroenterology (AIG) Hospital

Hyderabad, Andprad, India

Care Institute of Medical Sciences

Ahmedabad, Gujarat, India

Apollo Hospitals, Bangalore

Bangalore, Karnataka, India

Narayana Institute of Cardiac Sciences, Bommasandra

Bangalore, Karnataka, India

Medanta - The Medicity Hospital

Gūrgaon, India

Max Super Specialty Hospital

New Delhi, India

Mater Dei Hospital

Bari, Apulia, Italy

Azienda Ospedaliera Di Venere

Carbonara, Apulia, Italy

Azienda Ospedaliera Universitaria MaterDomini

Catanzaro, Calabria, Italy

Azienda Ospedaliera S. G. Moscati

Avellino, Italy

Chiba University

Chiba, Chiba, Japan

Hyogo College of Medicine

Nishinomiya, Hyōgo, Japan

St. Marianna University School of Medicine Hospital

Kawasaki, Kanagawa, Japan

Kitasato University Hospital

Sagamihara, Kanagwa, Japan

Amsterdam Academic Medical Centre (AMC)

Amsterdam, Noord-h, Netherlands

Scanmed SA

Krakow, Lesrpld, Poland

Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu

Poznan, Poland

Santa Maria Hospital

Lisbon, Portugal

Arrhythmia Group LLC

Ponce, Puerto Rico

Meshalkin National Medical Research Center

Novosibirsk, Siberia, Russia

King Fahad Armed Forces Hospital

Jeddah, Mecca Region, Saudi Arabia

King Faisal Specialist Hospital (KFSH)

Riyadh, Riyadh Region, Saudi Arabia

King Fahad Medical City

Riyadh, Saudi Arabia

Clinical Center of Serbia - Pacemaker Center

Belgrade, Serbia

Sejong Hospital

Bucheon-si, Sudogwn, South Korea

Keimyung University Dongsan Medical Center

Daegu, Sudogwn, South Korea

Seoul National University Bundang Hospital

Seongnam, Sudogwn, South Korea

Samsung Medical Center

Seoul, Sudogwon, South Korea

Keimyung University Dongsan Medical Center

Daegu, South Korea

Asan Medical Centre

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Hospital Universitario Infanta Cristina

Badajoz, Spain

Hospital Clínic de Barcelona

Barcelona, Spain

Fundación Jiménez Díaz

Madrid, Spain

Hospital Puerta de Hierro - Hospital Universitario

Madrid, Spain

HCU Virgen de la Victoria

Málaga, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

Karolinska University Hospital, Solna

Stockholm, Sweden

Taichung Veterans General Hospital

Taichung, Taiwan

Phramongkutklao Hospital

Bangkok, Central Thailand, Thailand

Southampton University Hospital

Southampton, Soeast, United Kingdom

John Radcliffe Hospital

Oxford, South East England, United Kingdom

The Royal Sussex County Hospital

Brighton, United Kingdom