Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads

NACompletedINTERVENTIONAL
Enrollment

2,244

Participants

Timeline

Start Date

April 14, 2014

Primary Completion Date

April 19, 2017

Study Completion Date

October 6, 2020

Conditions
Cardiac Resynchronization Therapy
Interventions
DEVICE

ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead

"The ACUITY X4 leads are intended for chronic left ventricular pacing and sensing. The leads have 3 tip configuration designs (straight tip, short tip spiral, and long tip spiral), which is intended to provide choices for patients with different anatomies.~The RELIANCE 4-FRONT leads are designed for right-side heart applications within the ventricle, atrium, and superior vena cava. It is intended for permanent sensing, pacing, and defibrillation when used with a compatible implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D).~Subjects were allowed to receive both the ACUITY X4 and RELIANCE 4-FRONT lead."

Trial Locations (96)

10032

Columbia University Medical Center, New York

10467

Montefiore Medical Center, The Bronx

11040

Long Island Jewish Medical Center, New Hyde Park

11219

Maimonides Medical Center, Brooklyn

11794

Stony Brook University Hospital, Stony Brook

14221

Buffalo General Hospital, Williamsville

Mercy Hospital of Buffalo, Catholic Health System, Williamsville

17403

York Hospital, York

18103

Lehigh Valley Hospital, Allentown

19001

Abington Memorial Hospital, Abington

21237

Union Memorial Hospital, Baltimore

23116

Bon Secours Heart & Vascular Institute, Mechanicsville

23225

Virginia Cardiovascular Specialist, Richmond

23507

Sentara Norfolk General Hospital, Norfolk

25304

Charleston Area Medical Center, Charleston

26505

Monongalia General Hospital, Morgantown

27599

University of North Carolina Hospital, Chapel Hill

27710

Duke University Medical Center, Durham

29303

Spartanburg Regional Medical Center, Spartanburg

29425

Medical University of South Carolina, Charleston

29506

PeeDee Cardiology Associates PA, Florence

30046

Gwinnett Hospital System Inc., Lawrenceville

30308

Emory University Hospital, Atlanta

32308

Tallahassee Memorial Hospital, Tallahassee

33334

Delray Medical Center, Fort Lauderdale

33606

Tampa General Hospital, Tampa

33770

West Florida Cardiology Network, LLC, Largo

35294

University of Alabama at Birmingham, Birmingham

35801

Huntsville Hospital, Huntsville

37205

St. Thomas Research Institute, LLC, Nashville

37215

Vanderbilt University Medical Center, Nashville

38138

Stern Cardiovascular Foundation, Inc., Germantown

38805

Lakeland Regional Medical Center, Lakeland

40202

University of Louisville Hospital, Louisville

40503

Baptist Health Lexington, Lexington

43210

Ohio State University Medical Center, Columbus

43214

OhioHealth Research and Innovation Institute - Riverside Methodist Hospital, Columbus

43615

The Toledo Hospital, Toledo

43952

Wheeling Hospital Inc., Steubenville

44195

Cleveland Clinic Foundation, Cleveland

44710

Aultman Hospital, Canton

45220

Good Samaritan Hospital, Cincinnati

46260

St. Vincent's Hospital, Indianapolis

46311

Porter Memorial Hospital, Dyer

47303

Ball Memorial Hospital, Muncie

48197

St. Joseph Mercy Hospital, Ypsilanti

48804

Lutheran Medical Group, Fort Wayne

49503

Spectrum Health Hospitals, Grand Rapids

52242

University of Iowa Hospitals and Clinics, Iowa City

55102

HealthEast St. Joseph's Hospital, Saint Paul

United Heart and Vascular Clinic, Saint Paul

55805

St. Mary's Duluth Clinic Regional Heart Center, Duluth

56303

St. Cloud Hospital, Saint Cloud

57108

Avera Heart Hospital of South Dakota, Sioux Falls

57701

Rapid City Regional Hospital, Rapid City

60007

Alexian Brothers Medical Center, Elk Grove Village

60637

University of Chicago, Chicago

62769

St. John's Hospital, Springfield

63110

Barnes Jewish Hospital, St Louis

64111

St. Luke's Hospital of Kansas City, Kansas City

65201

Boone Hospital Center, Columbia

65807

Cox Health, Springfield

66160

University of Kansas Hospital, Kansas City

68526

Nebraska Heart Institute, Lincoln

72401

Cardiology Associates of Northeast Arkansas, P.A., Jonesboro

75230

Medical City Dallas Hospital, Dallas

75231

Walnut Hill Medical Center, Dallas

75701

Trinity Mother Frances Health System, Tyler

76104

Plaza Medical Center of Fort Worth, Fort Worth

77384

University of Texas Houston Health Science Center, The Woodlands

77702

SouthEast Texas Clinical Research Center, Beaumont

78705

Texas Cardiac Arrhythmia Research, Austin

78756

Heart Hospital of Austin, Austin

84107

Intermountain Medical Center, Murray

85206

Banner Baywood Heart Hospital, Mesa

85258

Scottsdale Healthcare - Osborn, Scottsdale

90027

Kaiser Permanente, Los Angeles

90033

USC Medical Center, Los Angeles

92123

Sharp Memorial Hospital, San Diego

94609

Alta Bates Medical Center, Oakland

95819

Mercy General Hospital, Sacramento

97225

Providence St. Vincent Medical Center, Portland

97504

Asante Rogue Regional Medical Center, Medford

98201

Providence Regional Medical Center Everett, Everett

98225

PeaceHealth St. Joseph Medical Center, Bellingham

99204

Kootenai Heart Clinics, Spokane

Providence Health & Services - Washington, Spokane

99508

Providence Alaska Medical Center, Anchorage

06102

Hartford Hospital, Hartford

06510

Yale University School of Medicine, New Haven

04401

Eastern Maine Medical Center, Bangor

02215

Beth Israel Deaconess Medical Center, Boston

08015

Deborah Heart and Lung Center, Browns Mills

08035

Cooper Hospital - University Medical Center, Haddon Heights

07753

Jersey Shore University Medical Center, Neptune City

07450

Valley Hospital, Ridgewood

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY