Trial record 1 of 1 for:    NCT01064076
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S-ICD® System IDE Clinical Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Cameron Health, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Cameron Health, Inc.
ClinicalTrials.gov Identifier:
NCT01064076
First received: February 4, 2010
Last updated: October 8, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention
Tachycardia, Ventricular
Device: S-ICD System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: S-ICD® System Clinical Investigation

Resource links provided by NLM:


Further study details as provided by Cameron Health, Inc.:

Primary Outcome Measures:
  • Safety: The 180-day S-ICD System complication-free rate meets or exceeds the performance goal of 79%. [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • Effectiveness: The induced VF conversion efficacy rate meets or exceeds the performance goal of 88%. [ Time Frame: Implant/Pre-Discharge ] [ Designated as safety issue: No ]

Enrollment: 330
Study Start Date: January 2010
Estimated Study Completion Date: October 2013
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S-ICD System
This is a single arm study
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).
Other Names:
  • SQ-RX Pulse Generator
  • Q-TRAK Subcutaneous Electrode
  • Q-GUIDE Electrode Insertion Tools
  • Q-TECH Programmer

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01064076

  Show 33 Study Locations
Sponsors and Collaborators
Cameron Health, Inc.
Investigators
Study Director: Jon Hunt, Ph.D. Cameron Health, Inc.
  More Information

Additional Information:
No publications provided by Cameron Health, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cameron Health, Inc.
ClinicalTrials.gov Identifier: NCT01064076     History of Changes
Other Study ID Numbers: DN-03909
Study First Received: February 4, 2010
Last Updated: October 8, 2012
Health Authority: New Zealand: Medsafe
United States: Food and Drug Administration

Keywords provided by Cameron Health, Inc.:
ICD, defibrillator

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014