S-ICD® System IDE Clinical Study

Completed · Not applicable

Conditions studied: Tachycardia, Ventricular

In brief

This clinical study is designed to evaluate the safety and effectiveness of the subcutaneous implantable defibrillator (S-ICD) System.

Key facts

Study ID

NCT01064076

Run by

Boston Scientific Corporation

People needed

330

Starts

2010-01-01

Expected to finish

2013-01-01

Last updated by the study team

2017-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For patients without an existing transvenous device
• Patient meets Class I, Class IIa or Class IIb indications/recommendations for ICD implantation per the current published guidelines at the time of enrollment
• For patients with an existing transvenous device
• Patient requires replacement or revision of an existing implanted transvenous ICD system
• Age is ≥ 18 years
• An appropriate pre-operative ECG per template provided

You may not qualify if…

• Any condition which precludes the subject's ability to comply with the study requirements, including completion of the study.
• Females who are pregnant or lactating and pre-menopausal women who are unwilling to use adequate birth control for the duration of the study.
• Participation in any other investigational study without prior written consent from the study sponsor.
• Patients with a serious medical condition and life expectancy of less than one year.
• Patients with documented spontaneous and frequently recurring VT that is reliably terminated with anti-tachycardia pacing, unless the patient is not a candidate for a transvenous ICD system.
• Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant.
• Patients with unipolar pacemakers or implanted devices that revert to unipolar pacing.
• Patients with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with an estimated GFR ≤ 29.

Where it is running

• Arizona Arrhythmia Consultants — Scottsdale, Arizona, United States
• University of Southern California — Los Angeles, California, United States
• Foothill Cardiology — Pasadena, California, United States
• CMCA / Sequoia Hospital — Redwood City, California, United States
• Sharp Grossmont Hospital — San Diego, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• Pacific Heart Institute — Santa Monica, California, United States
• South Bay Electrophysiology — Torrance, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Midwest Heart Foundation — Oakbrook Terrace, Illinois, United States
• Parkview Research Center — Fort Wayne, Indiana, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Mid Carolina Cardiology Research — Charlotte, North Carolina, United States
• Forsyth Medical Center — Winston-Salem, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States
• Sentara Heart Hospital — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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