S-ICD® System IDE Clinical Study

NACompletedINTERVENTIONAL
Enrollment

330

Participants

Timeline

Start Date

January 31, 2010

Primary Completion Date

October 31, 2011

Study Completion Date

January 31, 2013

Conditions
Tachycardia, Ventricular
Interventions
DEVICE

S-ICD System

The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the SQ-RX pulse generator (Model 1010), the Q-TRAK subcutaneous electrode (Model 3010), the Q-TECH programmer (Model 2020), and Q-GUIDE electrode insertion tools (Models 4010 and 4020).

Trial Locations (33)

1001

Auckland City Hospital, Auckland

8140

Christchurch Hospital, Christchurch

10029

Mount Sinai School of Medicine, New York

19102

Drexel University College of Medicine, Philadelphia

19104

Hospital of the University of Pennsylvania, Philadelphia

20010

Washington Hospital Center, Washington D.C.

22042

Inova Fairfax Hospital, Falls Church

23507

Sentara Heart Hospital, Norfolk

27103

Forsyth Medical Center, Winston-Salem

28204

Mid Carolina Cardiology Research, Charlotte

29464

Medical University of South Carolina, Charleston

30308

Emory University School of Medicine, Atlanta

43210

The Ohio State University, Columbus

44195

Cleveland Clinic Foundation, Cleveland

46805

Parkview Research Center, Fort Wayne

60181

Midwest Heart Foundation, Oakbrook Terrace

60611

Northwestern University, Chicago

60637

University of Chicago, Chicago

85251

Arizona Arrhythmia Consultants, Scottsdale

90033

University of Southern California, Los Angeles

90404

Pacific Heart Institute, Santa Monica

90503

South Bay Electrophysiology, Torrance

91105

Foothill Cardiology, Pasadena

92123

Sharp Grossmont Hospital, San Diego

Sharp Memorial Hospital, San Diego

94062

CMCA / Sequoia Hospital, Redwood City

98195

University of Washington Medical Center, Seattle

98684

The Vancouver Clinic, Vancouver

99204

Heart Clinics Northwest, Spokane

08103

Cooper University Hospital, Camden

3435 CM

St. Antonius Ziekenhuis, Nieuwegein

3015 GD

Erasmus Medical Center, Rotterdam

CB3 8RE

Papworth Hospital NHS Trust, Papworth Everard

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY