NCT01117792

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2008

Shorter than P25 for not_applicable

Geographic Reach
4 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2010

Completed
11.2 years until next milestone

Results Posted

Study results publicly available

July 2, 2021

Completed
Last Updated

July 2, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

April 28, 2010

Results QC Date

June 11, 2021

Last Update Submit

July 1, 2021

Conditions

ACC/AHA/NASPE Class 1, IIa or IIb Indications

Outcome Measures

Primary Outcomes (1)

  • Conversion of Induced Ventricular Fibrillation

    The total number of subjects the S-ICD System was successful at converting induced sustained ventricular fibrillation.

    Testing done during the implant procedure

Study Arms (1)

S-ICD System

EXPERIMENTAL
Device: subcutaneous implantable defibrillator (S-ICD) system

Interventions

subcutaneous implantable defibrillator (S-ICD) systemDEVICE

implantable defibrillator system

S-ICD System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Policlinico San Donato

San Donato Milanese, 20097, Italy

Location

Academisch Medisch Centrum

Amsterdam, 1100 DD, Netherlands

Location

Universitair Medisch Centrum

Groningen, 9713 GZ, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3015 GD, Netherlands

Location

Auckland City Hospital

Auckland, 1001, New Zealand

Location

Christchurch Hospital

Christchurch, 8002, New Zealand

Location

Russells Hall Hospital

Dudley, DY1 2HQ, United Kingdom

Location

Related Publications (1)

  • Theuns DA, Crozier IG, Barr CS, Hood MA, Cappato R, Knops RE, Maass AH, Boersma LV, Jordaens L. Longevity of the Subcutaneous Implantable Defibrillator: Long-Term Follow-Up of the European Regulatory Trial Cohort. Circ Arrhythm Electrophysiol. 2015 Oct;8(5):1159-63. doi: 10.1161/CIRCEP.115.002953. Epub 2015 Jul 6.

    PMID: 26148819DERIVED

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Results Point of Contact

Title
Tom Stoltz, Clinical Trial Manager
Organization
Boston Scientific
thomas.stoltz@bsci.com
1-800-227-3422

Study Officials

  • Stephen O'Connor, PhD, Hon FRCP

    Boston Scientific Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2010

First Posted

May 5, 2010

Study Start

December 1, 2008

Primary Completion

March 1, 2009

Study Completion

August 1, 2009

Last Updated

July 2, 2021

Results First Posted

July 2, 2021

Record last verified: 2021-07

Locations

IT(1)GB(1)NZ(2)NL(4)