INcrease Of VAgal TonE in CHF

PHASE3TerminatedINTERVENTIONAL
Enrollment

730

Participants

Timeline

Start Date

February 28, 2011

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Left Ventricular DysfunctionHeart Failure
Interventions
DEVICE

CardioFit® System

Vagal nerve stimulation with the CardioFit® system

OTHER

Standard of Care

Usual care for LV dysfunction and heart failure (no CardioFit System implant)

Trial Locations (87)

3600

Ziekenhuis Oost Limburg, Genk

9300

Onze Lieve Vrouwziekenhuis, Aalst

10029

Mount Sinai, New York

10467

Montefiore Medical Center/Albert Einstein Colelge of Medicine, The Bronx

11000

Clinical Centre of Serbia, Belgrade

11080

Clinical Hosptial Centre Bezanijska Kosa, Belgrade

11794

Stony Brook University Medical Center, Stony Brook

12203

Charite Benjamin Franklin Campus, Berlin

13353

Charite Campus Virchow-Klinikum Medizinische Klinik mit Schwerpunkt Kardiologie, Berlin

15212

Allegheny General Hospital, Pittsburgh

17033

Hershey Medical Center/Penn State, Hershey

17602

Lancaster Heart and Stroke Foundation, Lancaster

19107

Thomas Jefferson University, Philadelphia

20099

Asklepios St Georg Hospital, Hamburg

22457

Albertinen-Krankenhaus, Hamburg

23507

Sentara Norfolk Hospital, Norfolk

29425

Medical University of South Carolina, Charleston

30322

Emory University, Atlanta

30342

St. Joseph's Hospital, Atlanta

30625

MHH Klinik für Kardiologie und Angiologie, Hanover

31048

Bnai-Zion Hospital, Haifa

31201

Georgia Arrhythmia Consultants, Macon

32224

Mayo Clinic Jacksonville, Jacksonville

32803

Florida Hospital, CV Research Institute, Orlando

33756

Clearwater Cardiovascular Consultants/Morton Plant, Clearwater

35294

University of Alabama Birmingham, Birmingham

37212

VA Tennessee Valley Healthcare System, Nashville

38801

Cardiology Associates of North Mississippi, Tupelo

43210

The Ohio State, Columbus

44109

MetroHealth Medical Center, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

44791

St. Josef Hospital, Bochum

46250

Community Heart and Vascular Clinic, Indianapolis

46260

Saint Vincent Medical Group, Indianapolis

48109

University of Michigan, Ann Arbor

48149

Uniklinikum Muenster, Münster

48201

Detroit Medical Center - Harper Hospital, Detroit

48202

Henry Ford Health System, Detroit

48334

Detroit Clinical Research Center/Botsford Hospital, Farmington Hills

48601

Michigan Cardiovascular Institute, Saginaw

49684

Munson Medical Center/Traverse Heart and Vascular, Traverse

50981

Fourth Military Hospital Wroclaw, Wroclaw

52074

Uniklinikum Aachen, Aachen

52242

University of Iowa, Iowa City

53147

Aurora Health Care, Lake Geneva

54449

Marshfield Clinic, Marshfield

55102

United Heart & Vascular, Saint Paul

55426

Park Nicollet / Methodist, Saint Louis Park

60453

Advocate Christ Medical Center, Oak Lawn

63110

Washington University, St Louis

63136

St. Louis Heart and Vascular, St Louis

64111

St. Luke's Mid America Heart Institute, Kansas City

68167

University of Medicine Mannheim, Mannheim

68506

Bryan Heart Institute, Lincoln

73120

Oklahoma Cardiovascular Research Group, Oklahoma City

75230

Dallas Cardiovascular Associates (CRSTI), Dallas

77030

EP Heart/ETHSC at Houston, Houston

St Lukes Episcopal, Houston

78705

Texas Cardiac Arrhythmia (TCA), Austin

79106

Lone Star Heart Center, Amarillo

80120

South Denver Cardiology, Denver

84132

University of Utah, Salt Lake City

85206

Banner Research Institute, Mesa

91204

Glendale Memorial Hospital, Glendale

91425

Medical University of Łodź, Łodź

91910

Chula Vista Heart Clinic, San Diego

95819

Sutter Memorial Hospital, Sacramento

98405

Multicare Health System, Tacoma

99204

Kootenai Heart Clinic, Spokane

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess, Boston

89169-2579

Health Care Partners Cardiology/St. Rose Hospital, Las Vegas

45267-0542

University of Cincinnati, Cincinnati

03000

Universitair Ziekenhuis Campus Gasthuisberg, Leuven

Unknown

University Medical Centre Groningen, Groningen

Maastricht University Medical Center, Maastricht

3015 CE

Erasmus University Medical Center Rotterdam, Rotterdam

G81 4DY

Golden Jubilee National Hospital, Clydebank

B15 2TH

Queen Elizabeth Hospital, Birmingham

FY3 8NR

Blackpool Victoria Hospital, Blackpool

KT16 0PZ

St. Peter's Hospital, Chertsey

HU16 5JQ

University of Hull/Castle Hill Hospital, Cottingham

CV2 2DX

University Hospital Coventry, Coventry

LE3 9QP

Glenfield Hospital, Leicester

SW3 6NP

Royal Brompton Hospital, London

OX3 9DU

Oxford University/John Radcliffe Hospital, Oxford

SO16 6YD

Southampton General Hospital, Southampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

BioControl Medical

INDUSTRY