Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction

NACompletedINTERVENTIONAL
Enrollment

1,173

Participants

Timeline

Start Date

June 9, 2015

Primary Completion Date

December 6, 2019

Study Completion Date

December 6, 2019

Conditions
Ventricular FibrillationVentricular TachycardiaLow Cardiac Output
Interventions
DEVICE

EMBLEM S-ICD System

The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp

Trial Locations (110)

1000

Clinique Saint-Jean, Brussels

5000

University Hospital, Odense

6900

Cardiocentro Ticino, Lugano

8091

University Hospital Zurich, Zurich

9000

Universitair Ziekenhuis Gent, Ghent

10003

Beth Israel Medical Center, New York

11040

Northwell Health, New Hyde Park

12208

Albany Medical Center, Albany

12687

Unfallkrankenhaus Berlin Marzahn, Berlin

13005

CHU La Timone Hospital, Marseille

13353

Deutsches Herzzentrum Berlin, Berlin

14642

Strong Memorial Hospital of the University of Rochester, Rochester

15213

University of Pittsburgh Medical Center, Pittsburgh

17475

Universitaetsmedizin Greifswald, Greifswald

19001

Abington Memorial Hospital, Abington

19713

Cardiology Physicians PA, Newark

20246

Universitaetsklinik Eppendorf, Hamburg

21079

CHU Dijon, Dijon

21804

Peninsula Cardiology Associates, Salisbury

23219

Virginia Commonwealth University Health System, Richmond

23507

Sentara Norfolk General Hospital, Norfolk

24127

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

24501

Centra Stroobants Cardiovascular Center, Lynchburg

27599

University of North Carolina Hospital, Chapel Hill

27607

Rex Hospital, Raleigh

27705

Durham VA Medical Center, Durham

28040

Hospital Clinico San Carlos, Madrid

28801

Memorial Mission Hospital, Asheville

29621

AnMed Health, Anderson

30322

Emory University Hospital, Atlanta

30901

University Hospital, Augusta

31076

Clinique Pasteur, Toulouse

32207

Baptist Medical Center, Jacksonville

32308

Tallahassee Memorial Hospital, Tallahassee

32803

Florida Hospital, Orlando

34295

CHU Montpellier, Montpellier

35205

Alabama Cardiovascular Group, Birmingham

35801

Huntsville Hospital - The Heart Center, PC, Huntsville

37126

Azienda Ospedaliera Universitaria Integrata di Verona, Verona

38801

North Mississippi Medical Center, Tupelo

43210

Ohio State University Medical Center, Columbus

43606

The Toledo Hospital, Toledo

43701

Genesis Healthcare System, Zanesville

44710

Aultman Hospital, Canton

45004

Hospital Virgen De La Salud, Toledo

46202

Methodist Hospital of Indianapolis, Indianapolis

46260

St. Vincent's Hospital, Indianapolis

48066

CardioVascular Institute of Michigan P.C., Roseville

48073

William Beaumont Hospital, Royal Oak

48106

St. Joseph Mercy Hospital, Ann Arbor

48149

University Hospital of Muenster, Münster

52242

University of Iowa Hospitals and Clinics, Iowa City

53715

St. Mary's Madison, Madison

54500

CHRU Nancy Brabois, Vandœuvre-lès-Nancy

55102

HealthEast St. Joseph's Hospital, Saint Paul

56127

Azienda Ospedaliero Universitaria Pisana, Pisa

56303

Centracare Heart and Vascular Center, Saint Cloud

60590

University Hospital Frankfurt, Frankfurt

60605

CorVita Science Foundation, Chicago

60611

Northwestern Memorial Hospital, Chicago

Northern Indiana Research Alliance - Lutheran Hospital, Fort Wayne

60637

University of Chicago, Chicago

65804

Mercy Research, Springfield

65807

Cox Health, Springfield

67091

Nouvel Hôpital Civil De Strasbourg, Strasbourg

67214

Heartland Cardiology, Wichita

68198

The Nebraska Medical Center, Omaha

69120

Universitaetsklinikum Heidelberg, Heidelberg

70121

Ochsner Clinic Foundation, New Orleans

71103

Advanced Cardiovascular Specialists, Shreveport

74011

CH Annecy, Annecy

75151

Hospital de la Pitie-Salpetriere, Paris

75701

Trinity Mother Frances Health System, Tyler

78229

South Texas Veterans Health Care System, San Antonio

84132

University of Utah Hospital and Clinics, Salt Lake City

85054

Mayo Clinic Phoenix, Phoenix

85297

Mercy Gilbert Medical Center, Gilbert

89169

HealthCare Partners Cardiology, Las Vegas

90502

Harbor UCLA Medical Center, Torrance

91206

Glendale Adventist Medical Center, Glendale

91942

Sharp Grossmont Hospital, La Mesa

92868

St. Joseph Hospital, Orange

94609

Alta Bates Medical Center, Oakland

95124

Good Samaritan Hospital - San Jose, San Jose

97301

Salem Hospital, Salem

97477

Sacred Heart Medical Center at Riverbend, Springfield

98034

Evergreen Hospital Medical Center, Kirkland

98405

CHI Franciscan Health System, Tacoma

90033-4612

University of Southern California Hospital, Los Angeles

06520

Yale University School of Medicine, New Haven

08015

Deborah Heart and Lung Center, Browns Mills

08103

Cooper Hospital - University Medical Center, Camden

08080

Cardiovascular Associates of the Delaware Valley, Sewell

29425-0001

Medical University of South Carolina, Charleston

G1V 4G5

Institut universitaire de Cardiologie et de Pneumologie de Quebec, Ste-Foy

Unknown

CHRU de Lille, Lille

CHRU Hopital Pontchaillou, Rennes

Hospital Miguel Servet, Zaragoza

Russels Hall Hospital, Dudley

Glenfield Hospital, Leicester

1105 AZ

Academisch Medisch Centrum, Amsterdam

3430 EM

St. Antonius Ziekenhuis, Nieuwegein

3015 GD

Erasmus MC - University Medical Center Rotterdam, Rotterdam

92-213

Centralny Szpital Kliniczny Uniwerytetu Medycznego, Lodz

00733

Hospital San Lucas, Ponce

FY3 8NR

Blackpool Victoria NHS Trust Direct, Blackpool

L14 3PE

Cardiothoracic Centre, Liverpool

EC1A 7BE

St. Bartholomews Hospital, London

S5 7AU

Northern General Hospital, Sheffield

S016 6YD

Southampton University Hospital, Southampton

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY

NCT02433379 - Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction | Biotech Hunter | Biotech Hunter