S-ICD® System IDE Clinical Study

Tachycardia, Ventricular Clinical Trial

Official title:

S-ICD® System Clinical Investigation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01064076
• Other study ID #: DN-03909
• Status: Active, not recruiting
• Phase: N/A
• First received: February 4, 2010
• Last updated: October 8, 2012
• Start date: January 2010
• Est. completion date: October 2013

Study information

• Verified date: October 2012
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: MedsafeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 330
• Est. completion date: October 2013
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular

Intervention

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).

Locations

Country	Name	City	State
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	Erasmus Medical Center	Rotterdam
New Zealand	Auckland City Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch
United Kingdom	Papworth Hospital NHS Trust	Papworth Everard	Cambridge
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Cooper University Hospital	Camden	New Jersey
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Mid Carolina Cardiology Research	Charlotte	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Parkview Research Center	Fort Wayne	Indiana
United States	University of Southern California	Los Angeles	California
United States	Mount Sinai School of Medicine	New York	New York
United States	Sentara Heart Hospital	Norfolk	Virginia
United States	Midwest Heart Foundation	Oakbrook Terrace	Illinois
United States	Foothill Cardiology	Pasadena	California
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
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	Arizona Arrhythmia Consultants	Scottsdale	Arizona
United States	University of Washington Medical Center	Seattle	Washington
United States	Heart Clinics Northwest	Spokane	Washington
United States	South Bay Electrophysiology	Torrance	California
United States	The Vancouver Clinic	Vancouver	Washington
United States	Washington Hospital Center	Washington	District of Columbia
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Netherlands,  New Zealand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: The 180-day S-ICD System complication-free rate meets or exceeds the performance goal of 79%.		180 days	Yes
Primary	Effectiveness: The induced VF conversion efficacy rate meets or exceeds the performance goal of 88%.		Implant/Pre-Discharge	No

External Links

•   Cameron Health's Website