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NCT01064076 · ClinicalTrials.gov registry record · NA
S-ICD® System IDE Clinical Study
A NA study of Tachycardia, Ventricular, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- NA
- Development phase
- 330
- Enrollment target
- 20
- Study locations
NCT01064076: Completed NA study of Tachycardia, Ventricular, sponsored by Boston Scientific Corporation.
NCT01064076 is a NA study of Tachycardia, Ventricular that has completed, run by Boston Scientific Corporation. The registered enrollment target is 330 participants, above the 219-participant average among 4 other Tachycardia, Ventricular trials with a reported enrollment target (51% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01064076, a NA study of Tachycardia, Ventricular, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 330 participants
- Enrollment target
- 20
- Study locations
Study Summary
This clinical study is designed to evaluate the safety and effectiveness of the subcutaneous implantable defibrillator (S-ICD) System.
Primary Outcome
Percentage of Participants Free of Type I Complications at 180 days compared to the performance goal of 79%. Type I complications are those caused by the S-ICD System.
Conditions Studied
Interventions
- DEVICE S-ICD System
Study Locations (20)
California
- University of Southern California - Los Angeles
- Foothill Cardiology - Pasadena
- CMCA / Sequoia Hospital - Redwood City
- Sharp Grossmont Hospital - San Diego
- Sharp Memorial Hospital - San Diego
- Pacific Heart Institute - Santa Monica
- South Bay Electrophysiology - Torrance
Illinois
- Northwestern University - Chicago
- University of Chicago - Chicago
- Midwest Heart Foundation - Oakbrook Terrace
North Carolina
- Mid Carolina Cardiology Research - Charlotte
- Forsyth Medical Center - Winston-Salem
Ohio
- Cleveland Clinic Foundation - Cleveland
- The Ohio State University - Columbus
Arizona
- Arizona Arrhythmia Consultants - Scottsdale
District of Columbia
- Washington Hospital Center - Washington D.C.
Georgia
- Emory University School of Medicine - Atlanta
Indiana
- Parkview Research Center - Fort Wayne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2010-01 |
| Est. Completion | 2013-01 |
| Phase | NA |
What the finished NCT01064076 record still lists
NCT01064076 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, above the 219-participant average among 4 other Tachycardia, Ventricular trials with a reported enrollment target (51% higher).
The record links to 1 condition, with Tachycardia, Ventricular appearing as the primary indexed condition, and to 1 intervention - of which S-ICD System is the first listed.
NCT01064076 names 20 study sites across 10 states, led by California, Illinois, North Carolina.
Frequently Asked Questions
What is clinical trial NCT01064076 about?
NCT01064076 is a clinical study titled "S-ICD® System IDE Clinical Study". This clinical study is designed to evaluate the safety and effectiveness of the subcutaneous implantable defibrillator (S-ICD) System.
What is the current status of trial NCT01064076?
This trial is currently completed. It is a NA study. The enrollment target is 330 participants. The study started on 2010-01. Estimated completion is 2013-01.
What conditions does trial NCT01064076 study?
This clinical trial studies the following conditions: Tachycardia, Ventricular.
What interventions are being tested in trial NCT01064076?
The interventions under investigation include: S-ICD System (DEVICE).
Who is sponsoring clinical trial NCT01064076?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01064076 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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