Respicardia, Inc. Pivotal Trial of the remedē System

NACompletedINTERVENTIONAL
Enrollment

151

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

September 10, 2016

Study Completion Date

November 7, 2017

Conditions
Sleep Apnea, CentralSleep Disordered BreathingHeart Failure
Interventions
DEVICE

Treatment Group (transvenous stimulation of the phrenic nerve)

device implant, optimal medical therapy and device initiation 1 month post implant.

DEVICE

Control Group (Optimal Medical Therapy)

device implant, optimal medical therapy and delayed device initiation (7 months post device implant)

Trial Locations (30)

17603

Lancaster General Hospital, Lancaster

19104

Hospital of University of Pennsylvania, Philadelphia

21201

University of Maryland, Baltimore, Baltimore

21287

Johns Hopkins Bayview Medical Center, Baltimore

23219

Virginia Commonwealth University, Richmond

27103

Forsyth Medical Center - Novant, Winston-Salem

28204

Novant Medical Group, Inc. Presbyterian Sleep Health Charlotte, Charlotte

32209

University of Florida - Jacksonville, Jacksonville

38138

Stern Cardiovascular, Memphis

43210

Ohio State University, Columbus

45219

The Lindner Center for Research and Education at Christ Hospital, Cincinnati

48334

Detroit Clinical Research Center, Farmington Hills

49525

Spectrum Health, Grand Rapids

54449

Marshfield Clinic, Marshfield

55102

United Heart and Vascular (Allina), Saint Paul

60566

Advocate Medical Group, Downers Grove

Edward Hospital-Advocate Medical Group, Naperville

63110

Washington University, St Louis

64111

Mid America Heart Institute, Kansas City

68506

Bryan Heart, Lincoln

78229

Methodist Healthcare System, San Antonio

90033

Keck Hospital of USC, Los Angeles

08034

Cooper Health System, Cherry Hill

Unknown

Bad Oeynhausen- Heart & Diabetes Center, Bad Oeynhausen

Charite Medical School, Campus Virchow-Klinikum, Berlin

Bernau-Herzzentruym Brandenburg, Bernau

Bielefeld-Klinikun, Bielefeld

Hamburg: Universitares Herzzentrum, Hamburg

Ambulantes Herzzentrum-Kassel, Kassel

Fourth Military Hospital, Wroclaw

All Listed Sponsors
lead

Respicardia, Inc.

INDUSTRY

NCT01816776 - Respicardia, Inc. Pivotal Trial of the remedē System | Biotech Hunter | Biotech Hunter