Clinical trial NCT01064076: S-ICD® System IDE Clinical Study
Official title: S-ICD® System Clinical Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tachycardia, Ventricular
Keywords: ICD, defibrillator
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2010-02-08
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Free of Type I Complications at 180 Days.
timeFrame: 180 days
measure: Percentage of Participants Who Pass Induced VF Conversion Test
timeFrame: Implant/Pre-Discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Arrhythmia Consultants
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Pasadena
country: United States
facility: Foothill Cardiology
state: California
city: Redwood City
country: United States
facility: CMCA / Sequoia Hospital
state: California
city: San Diego
country: United States
facility: Sharp Grossmont Hospital
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Santa Monica
country: United States
facility: Pacific Heart Institute
state: California
city: Torrance
country: United States
facility: South Bay Electrophysiology
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Midwest Heart Foundation
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Charlotte
country: United States
facility: Mid Carolina Cardiology Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Heart Hospital
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Spokane
country: United States
facility: Heart Clinics Northwest
state: Washington
city: Vancouver
country: United States
facility: The Vancouver Clinic
state: Washington
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Papworth Everard
country: United Kingdom
facility: Papworth Hospital NHS Trust
state: Cambridge
Study officials:
affiliation: Cameron Health, Inc. a Subsidiary of Boston Scientific
name: Michael Husby, M.S., MPH
role: STUDY_DIRECTOR
References:
citation: Amin AK, Gold MR, Burke MC, Knight BP, Rajjoub MR, Duffy E, Husby M, Stahl WK, Weiss R. Factors Associated With High-Voltage Impedance and Subcutaneous Implantable Defibrillator Ventricular Fibrillation Conversion Success. Circ Arrhythm Electrophysiol. 2019 Apr;12(4):e006665. doi: 10.1161/CIRCEP.118.006665.
citation: Burke MC, Gold MR, Knight BP, Barr CS, Theuns DAMJ, Boersma LVA, Knops RE, Weiss R, Leon AR, Herre JM, Husby M, Stein KM, Lambiase PD. Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator: 2-Year Results From a Pooled Analysis of the IDE Study and EFFORTLESS Registry. J Am Coll Cardiol. 2015 Apr 28;65(16):1605-1615. doi: 10.1016/j.jacc.2015.02.047.
citation: Weiss R, Knight BP, Gold MR, Leon AR, Herre JM, Hood M, Rashtian M, Kremers M, Crozier I, Lee KL, Smith W, Burke MC. Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation. 2013 Aug 27;128(9):944-53. doi: 10.1161/CIRCULATIONAHA.113.003042.