S-ICD® System IDE Clinical Study
This trial is active, not recruiting.
|Sponsor||Cameron Health, Inc.|
|Start date||January 2010|
|End date||October 2011|
|Trial size||330 participants|
|Trial identifier||NCT01064076, DN-03909|
This clinical study is designed to evaluate the safety and effectiveness of the subcutaneous implantable defibrillator (S-ICD) System.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
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|Scottsdale, AZ||Arizona Arrhythmia Consultants||no longer recruiting|
|Los Angeles, CA||University of Southern California||no longer recruiting|
|Pasadena, CA||Foothill Cardiology||no longer recruiting|
|Redwood City, CA||CMCA / Sequoia Hospital||no longer recruiting|
|San Diego, CA||Sharp Memorial Hospital||no longer recruiting|
|San Diego, CA||Sharp Grossmont Hospital||no longer recruiting|
|Santa Monica, CA||Pacific Heart Institute||no longer recruiting|
|Torrance, CA||South Bay Electrophysiology||no longer recruiting|
|Washington, DC||Washington Hospital Center||no longer recruiting|
|Atlanta, GA||Emory University School of Medicine||no longer recruiting|
|Chicago, IL||University of Chicago||no longer recruiting|
|Chicago, IL||Northwestern University||no longer recruiting|
|Oakbrook Terrace, IL||Midwest Heart Foundation||no longer recruiting|
|Fort Wayne, IN||Parkview Research Center||no longer recruiting|
|Camden, NJ||Cooper University Hospital||no longer recruiting|
|New York, NY||Mount Sinai School of Medicine||no longer recruiting|
|Charlotte, NC||Mid Carolina Cardiology Research||no longer recruiting|
|Winston-Salem, NC||Forsyth Medical Center||no longer recruiting|
|Cleveland, OH||Cleveland Clinic Foundation||no longer recruiting|
|Columbus, OH||The Ohio State University||no longer recruiting|
|Philadelphia, PA||Hospital of the University of Pennsylvania||no longer recruiting|
|Philadelphia, PA||Drexel University College of Medicine||no longer recruiting|
|Charleston, SC||Medical University of South Carolina||no longer recruiting|
|Falls Church, VA||Inova Fairfax Hospital||no longer recruiting|
|Norfolk, VA||Sentara Heart Hospital||no longer recruiting|
|Seattle, WA||University of Washington Medical Center||no longer recruiting|
|Spokane, WA||Heart Clinics Northwest||no longer recruiting|
|Vancouver, WA||The Vancouver Clinic||no longer recruiting|
|Nieuwegein, Netherlands||St. Antonius Ziekenhuis||no longer recruiting|
|Rotterdam, Netherlands||Erasmus Medical Center||no longer recruiting|
|Auckland, New Zealand||Auckland City Hospital||no longer recruiting|
|Christchurch, New Zealand||Christchurch Hospital||no longer recruiting|
|Papworth Everard, United Kingdom||Papworth Hospital NHS Trust||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Safety: The 180-day S-ICD System complication-free rate meets or exceeds the performance goal of 79%.
time frame: 180 days
Effectiveness: The induced VF conversion efficacy rate meets or exceeds the performance goal of 88%.
time frame: Implant/Pre-Discharge
Male or female participants at least 18 years old.
- 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
- 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.
|Official title||S-ICD® System Clinical Investigation|
|Description||This clinical study is a prospective, non-randomized, multicenter clinical study without a control group conducted in the United States, Europe, and New Zealand. Patients meeting eligibility criteria for implanting an S-ICD System will be enrolled in this clinical study, implanted with an S-ICD System, and followed prior to hospital discharge, and post-implant at 30 days, 90 days, and 180 days. After the 180-day post-implant follow-up visit, patients will continue to be followed semi-annually until study closure. Eligible patients enrolled in this clinical study may also participate in the chronic conversion sub-study. The safety endpoint will be evaluated through the use of a 180-day S-ICD System complication-free rate. The effectiveness endpoint will be evaluated using an induced ventricular fibrillation (VF) conversion efficacy rate. Spontaneous episodes and chronic conversion testing data will be evaluated using descriptive statistics to provide additional data supporting the continued chronic performance of the S-ICD System.|
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