SyncAV Post-Market Trial

NAActive, not recruitingINTERVENTIONAL
Enrollment

1,686

Participants

Timeline

Start Date

October 3, 2019

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Congestive Heart Failure
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.

Trial Locations (103)

8036

Universitätsklinik Graz, Graz

10400

Phramongkutklao Hospital, Bangkok

11215

New York Presbyterian Brooklyn Methodist Hospital, Brooklyn

12713

King Faisal Specialist Hospital (KFSH), Riyadh

15213

University of Pittsburgh Medical Center, Pittsburgh

23507

Sentara Norfolk General Hospital, Norfolk

29425

Medical University of South Carolina, Charleston

30309

Piedmont Heart Institute, Atlanta

30322

Emory University Hospital, Atlanta

31059

CHU Rangueil Toulouse, Toulouse

32610

Shands at the University of Florida, Gainesville

33328

Heart Rhythm Solutions, Hollywood

35801

Heart Center Research, LLC., Huntsville

40503

Baptist Health Lexington, Lexington

42601

Keimyung University Dongsan Medical Center, Daegu

43606

The Toledo Hospital, Toledo

44195

Cleveland Clinic Foundation, Cleveland

48912

Sparrow Clinical Research Institute, Lansing

50266

Iowa Heart Center, West Des Moines

63110

Washington University School of Medicine, St Louis

70125

Mater Dei Hospital, Bari

70131

Azienda Ospedaliera Di Venere, Carbonara

73102

Hightower Clinical, Oklahoma City

77030

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

77094

Memorial Katy Cardiology Associates, Houston

77380

Heart Rhythm Associates, Shenandoah

78201

South Texas Cardiovascular Consultants, San Antonio

80228

Colorado Heart & Vascular, P.C., Lakewood

85016

Arizona Cardiovascular Research Center, Phoenix

85258

HonorHealth, Scottsdale

88100

Azienda Ospedaliera Universitaria MaterDomini, Catanzaro

93309

Comprehensive Cardiovascular, Bakersfield

93720

Cardiovascular Consultants Heart Center, Fresno

94010

Hopital Henri Mondor, Créteil

97405

CHR de La Reunion - Site du CHFG, Saint-Denis

300041

Tianjin Chest Hospital, Tianjin

310016

Sir Run Run Shaw Hospital, Hangzhou

380060

Care Institute of Medical Sciences, Ahmedabad

500082

Asian Institute of Gastroenterology (AIG) Hospital, Hyderabad

560076

Apollo Hospitals, Bangalore, Bangalore

560099

Narayana Institute of Cardiac Sciences, Bommasandra, Bangalore

710061

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an

90033-5313

USC University Hospital, Los Angeles

03102

Catholic Medical Center, Manchester

08015

Deborah Heart & Lung Center, Browns Mills

08035

Cardiovascular Associates of the Delaware Valley, Haddon Heights

08043

Lourdes Cardiology Services, Voorhees Township

Unknown

Hopital Erasme, Brussels

Royal Jubilee Hospital, Victoria

QE II Health Sciences, Halifax

St. Mary's General Hospital, Kitchener

McGill University Health Centre General Hospital, Montreal

Royal Alexandra Hospital, Edmonton

CHUM, Montreal

Helsinki University Central Hospital (HYKS), Helsinki

CHRU Hopital de Pontchaillou, Rennes

St-Etienne CHU, Saint-Priest-en-Jarez

Klinikum der Ruprecht-Karls-Universität Heidelberg, Heidelberg

Herzzentrum Dresden GmbH Universitätsklinik, Dresden

Kerckhoff-Klinik gGmbH, Bad Nauheim

The University of Hong Kong (Queen Mary Hospital), Hong Kong

Medanta - The Medicity Hospital, Gūrgaon

Max Super Specialty Hospital, New Delhi

Azienda Ospedaliera S. G. Moscati, Avellino

Chiba University, Chiba

Scanmed SA, Krakow

Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu, Poznan

Santa Maria Hospital, Lisbon

Arrhythmia Group LLC, Ponce

Meshalkin National Medical Research Center, Novosibirsk

King Fahad Armed Forces Hospital, Jeddah

King Fahad Medical City, Riyadh

Clinical Center of Serbia - Pacemaker Center, Belgrade

Sejong Hospital, Bucheon-si

Keimyung University Dongsan Medical Center, Daegu

Asan Medical Centre, Seoul

Severance Hospital, Yonsei University Health System, Seoul

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

Karolinska University Hospital, Solna, Stockholm

Taichung Veterans General Hospital, Taichung

The Royal Sussex County Hospital, Brighton

T2N 2T9

Foothills Medical Centre, Calgary

V6Z 2E8

St. Paul's Hospital, Vancouver

H4J 1C5

Hopital du Sacre-Coeur de Montreal, Montreal

A1B 3V6

HSC, Eastern Health, St. John's

K7L 2V7

Kingston General Hospital, Kingston

M1B 4Z8

Cardiac Arrhythmia Research Group Inc. (CARGI), Scarborough Village

M5B 1WB

St. Michael's Hospital, Toronto

H1T 1C8

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

G1V 4G5

Institut de Cardiologie de Quebec (Hôpital Laval), Québec

J1H 5N4

CHUS Fleurimont, Sherbrooke

663-8501

Hyogo College of Medicine, Nishinomiya

216-8511

St. Marianna University School of Medicine Hospital, Kawasaki

252-0375

Kitasato University Hospital, Sagamihara

1105 AZ

Amsterdam Academic Medical Centre (AMC), Amsterdam

463-707

Seoul National University Bundang Hospital, Seongnam

SO16 6YD

Southampton University Hospital, Southampton

OX3 9DU

John Radcliffe Hospital, Oxford

Sponsors
All Listed Sponsors
lead

Abbott Medical Devices

INDUSTRY