Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices

CompletedOBSERVATIONAL
Enrollment

975

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

December 31, 2014

Study Completion Date

July 31, 2015

Conditions
Heart Failure
Interventions
DEVICE

COGNIS CRT-D

"Patients with existing or newly implanted COGNIS® CRT-D pulse generators (PG)are enrolled in the study. PG is modified by the download of investigational software called Sensor Research Device-1™ (SRD-1). The goal of the SRD-1 system is to collect sensor data without affecting the delivered CRT-D therapy. This is accomplished through the conversion of an implanted COGNIS PG into a SRD-1 PG by downloading investigational software. Only a market approved COGNIS model N119/N120/P107/P108 device may be converted to a SRD-1 investigational device. There will be no PG hardware changes resulting from the conversion."

Trial Locations (99)

1096

Hungarian Institute of Cardiology, Budapest

1122

Semmelweis University, Cardiovascular Center, Budapest

1134

Allami Egeszsegugyi Kozpont (AEK) Hospital, Budapest

2911

University of VA Medical Center, Charlottesville

10400

Ramathibodi Hospital, Bangkok

10467

Montefiore Medical Center, The Bronx

11040

Long Island Jewish Medical Center, New Hyde Park

11215

New York Methodist Hospital, Brooklyn

14642

Strong Memorial Hospital of the University of Rochester, Rochester

15213

University of Pittsburgh Medical Center, Pittsburgh

17033

Penn State Milton S. Hershey Medical Center, Hershey

17604

Lancaster General Hospital, Lancaster

18940

The Arrhythmia Institute, Newton

19001

Abington Memorial Hospital, Abington

19067

Cardiology Consultants of Philadelphia, Yardley

19141

Albert Einstein Medical Center, Philadelphia

23219

Virgina Commonwealth University Hospital System, Richmond

23225

Chippenham Medical Center, Richmond

23507

Sentara Norfolk General Hospital, Norfolk

26341

Rogue Valley Medical Center, Medford

26505

Monongalia General Hospital, Morgantown

28203

Sanger Heart and Vascular Institution, Charlotte

29425

Medical University of South Carolina, Charleston

30060

Wellstar Research Institute, Marietta

30322

Emory University Hospital, Atlanta

30342

St Joseph's Hospital of Atlanta, Atlanta

30501

Northeast Georgia Heart Center, Gainesville

32114

Daytona Heart Group, Daytona Beach

32216

First Coast Cardiovascular, Jacksonville

32806

Orlando Heart Center, Orlando

33805

Lakeland Regional Medical Center, Lakeland

33881

Winter Haven Hospital, Winter Haven

37024

Ospedale Sacro Cuore Don Calabria, Negrar

38120

Stern Cardiovascular Foundation, Inc., Memphis

40503

Central Baptist Hospital, Lexington

40504

St. Joseph Hospital, Lexington

43210

Ohio State University Medical Center, Columbus

43215

Ohio Health Research and Innovation Institute - Riverside Methodist Hospital, Columbus

43615

Northwest Ohio Cardiology, Toledo

44514

St. Elizabeth Health Center, Poland

44708

Cardiovascular Research Institute LLC, Canton

45219

The Christ Hospital, Cincinnati

45220

Good Samaritan Hospital, Cincinnati

46250

La Porte Hospital, La Porte

46260

St. Vincent's Hospital, Indianapolis

46804

Northern Indiana Research Alliance, Fort Wayne

46845

Parkview Hospital, Inc., Fort Wayne

47750

St. Mary's Medical Center, Evansville

48075

Providence Hospital, Southfield

48106

St Joseph Mercy Hospital, Ann Arbor

48601

Michigan Cardiovascular Institute, Saginaw

50400

Institut Jantung Negara, Kuala Lumpur

52043

St. Luke's Hospital, Cedar Rapids

52803

Genesis Medical Center, Davenport

55102

HealthEast St. Joseph's Hospital, Saint Paul

55455

Univeristy of MN Medical Center, Minneapolis

60068

Advocate Lutheran General Hospital, Park Ridge

60100

Az. Osp. Lancisi, Ancona

60637

University of Chicago Hospital, Chicago

65691

Faculty Hospital U sv Anny, Brno

68124

Bergan Cardiology -Alegent Bergan Mercy Medical Center, Omaha

72401

Cardiology Associates of Northeast Arkansas, Jonesboro

74104

Oklahoma Heart Institute, Tulsa

76100

Kaplan Medical Centre, Rehovot

77030

EP Heart, Houston

77205

Baptist Health Medical Center, Little Rock

77702

South East Texas Clinical Research, Beaumont

78705

Texas Cardiac Arrhythmia Research, Austin

78756

Heart Hospital of Austin, Houston

83348

The National Institute of Cardiovascular Diseases - NUSCH, Bratislava

84112

University of Utah Hospital and Clinics, Salt Lake City

85032

Cardiovascular Consultants, LTD, Phoenix

85206

Tri-City Cardiology, Mesa

85297

Arizona Advanced Arrhythmias, Gilbert

85712

Pima Heart Physicians, PC, Tucson

85723

Southern Arizona VA Health Care System, Tucson

90033

LAC & USC Medical Center, Los Angeles

92123

Sharp Memorial Hospital, San Diego

94115

California Pacific Medical Center, San Francisco

99508

Providence Alaska Medical Center, Anchorage

999077

Prince of Wales Hospital, Shatin

94609-3102

John Muir Medical Center, Oakland

06102-5037

Hartford Hospital, Hartford

20010-2975

Washington Hospital Center, Washington D.C.

01655

University of Massachusetts Memorial Medical Center, Worcester

07601-1963

Hackensack University Medical Center, Hackensack

07962

Morristown Memorial Hospital, Morristown

08080

Cardiovascular Associates of the Delaware Valley, Sewell

07052

New Jersey Cardiology Associates, West Orange

14221-5538

Buffalo Cardiology and Pulmonary, Williamsville

02903

Rhode Island Hospital, Providence

02904

Cardiovascular Associates of Rhode Island, Providence

07747

University Hospital Jena Cardiology, Jena

2333 ZA

Leiden University Medical Center, Leiden

3584 CX

Universitair Medisch Centrum, Utrecht

04011

VUSCH a.s., Košice

Unknown

Her Majesty Cardiac Center, Siriraj Hospital, Bangkok

G81 4HX

Golden Jubilee National Hospital, Clydebank

W1G 8PH

The Heart Hospital, London

Sponsors
All Listed Sponsors
collaborator

Milton S. Hershey Medical Center

OTHER

lead

Boston Scientific Corporation

INDUSTRY