NCT00853645

Brief Summary

Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system. A maximum of 10 subjects were to be enrolled and followed for one month to collect data on the safety, efficacy, and performance of the implanted S-ICD system. Additionally, patient comfort will be assessed as will cosmetic outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 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

July 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 2, 2009

Completed
12.3 years until next milestone

Results Posted

Study results publicly available

June 29, 2021

Completed
Last Updated

July 6, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

February 27, 2009

Results QC Date

June 10, 2021

Last Update Submit

July 1, 2021

Conditions

Ventricular Tachyarrhythmias

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With a Successful Induced Ventricular Fibrillation Conversion

    Sustained ventricular fibrillation induced by the investigator is successfully converted. A successful conversion was defined as two consecutive successful shocks out of four attempts with either standard polarity or with reverse polarity.

    30 days

Study Arms (1)

Subcutaneous implantable cardioverter defibrillator (S-ICD) System

EXPERIMENTAL

Single-arm with 6 patients implanted with an S-ICD System

Device: Subcutaneous Implantable Defibrillator (S-ICD) System

Interventions

Subcutaneous Implantable Defibrillator (S-ICD) SystemDEVICE
Subcutaneous implantable cardioverter defibrillator (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 transvenous implantable cardioverter defibrillator (ICD) system
  • American College of Cardiology/American Heart Association/Heart Rhythm Society (ACC/AHA/HRS) Class I or II indications for ICD implantation
  • Age \>= 18 years
  • Appropriate pre-operative Electrocardiogram (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 ventricular tachyarrhythmias (VT) that is reliably terminated with anti-tachycardia pacing
  • Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant
  • Patients with chronic renal failure, i.e. with a creatinine level of \>2.5 mg/dl unless prescribed drug therapy known to increase creatinine levels in which case the value should be \<= 3mg/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Auckland City Hospital

Auckland, 1001, New Zealand

Location

Christchurch Hospital

Christchurch, 8140, New Zealand

Location

Related Publications (1)

  • Bardy GH, Smith WM, Hood MA, Crozier IG, Melton IC, Jordaens L, Theuns D, Park RE, Wright DJ, Connelly DT, Fynn SP, Murgatroyd FD, Sperzel J, Neuzner J, Spitzer SG, Ardashev AV, Oduro A, Boersma L, Maass AH, Van Gelder IC, Wilde AA, van Dessel PF, Knops RE, Barr CS, Lupo P, Cappato R, Grace AA. An entirely subcutaneous implantable cardioverter-defibrillator. N Engl J Med. 2010 Jul 1;363(1):36-44. doi: 10.1056/NEJMoa0909545. Epub 2010 May 12.

    PMID: 20463331DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Results Point of Contact

Title
Gena Kantor, MPH
Organization
Boston Scientific
gena.kantor@bsci.com
1-800-227-3422

Study Officials

  • Stephen O'Connor, PhD, Hon FRACP

    Boston Scientific Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

February 27, 2009

First Posted

March 2, 2009

Study Start

July 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

July 6, 2021

Results First Posted

June 29, 2021

Record last verified: 2021-07

Locations

NZ(2)