Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01117792
First received: April 28, 2010
Last updated: May 4, 2010
Last verified: May 2010
  Purpose

The primary objective is to evaluate the S-ICD system's ability to identify and terminate induced ventricular fibrillation in patients during the implant procedure. The safety and performance of the S-ICD system will also be assessed throughout the patient follow-up period.


Condition Intervention
ACC/AHA/NASPE Class 1, IIa or IIb Indications
Device: subcutaneous implantable defibrillator (S-ICD) system

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Conversion of induced ventricular fibrillation [ Time Frame: testing done during the implant procedure ] [ Designated as safety issue: Yes ]
    Data was reported at 30 days and 6 months


Enrollment: 55
Study Start Date: December 2008
Study Completion Date: August 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S-ICD System Device: subcutaneous implantable defibrillator (S-ICD) system
implantable defibrillator system

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Replacement of an existing implanted transvenous ICD system
  • Class I, Class IIa, or Class IIb ACC/AHA/HRS indications for patients without an existing transvenous ICD system
  • Age is >= 18 years
  • Appropriate pre-operative ECG as measured with a specially developed template

Exclusion Criteria:

  • Subjects unable or unwilling to provide informed consent
  • Any condition which precludes the subject's ability to comply with the study requirements
  • 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 another investigational device trial at any time during the conduct of the S-ICD system trial without written consent from the 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
  • Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant
  • Patients with impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with a 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: NCT01117792

Locations
Italy
Policlinico San Donato
San Donato Milanese, Italy, 20097
Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands, 1100 DD
Universitair Medisch Centrum
Groningen, Netherlands, 9713 GZ
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435 CM
Erasmus Medical Center
Rotterdam, Netherlands, 3015 GD
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1001
Christchurch Hospital
Christchurch, New Zealand, 8002
United Kingdom
Russells Hall Hospital
Dudley, United Kingdom, DY1 2HQ
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Stephen O'Connor, PhD, Hon FRCP Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Stephen A. O'Connor, Ph.D., Hon FRCP, Cameron Health, Inc.
ClinicalTrials.gov Identifier: NCT01117792     History of Changes
Other Study ID Numbers: DN-01040
Study First Received: April 28, 2010
Last Updated: May 4, 2010
Health Authority: Netherlands: Dutch Health Care Inspectorate
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ministry of Health
New Zealand: Medsafe

ClinicalTrials.gov processed this record on November 20, 2014