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Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System (Chronic II)

Primary Purpose

Ventricular Tachyarrhythmias

Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Subcutaneous Implantable Defibrillator (S-ICD) System
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Ventricular Tachyarrhythmias

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

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 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

Sites / Locations

  • Auckland City Hospital
  • Christchurch Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subcutaneous implantable cardioverter defibrillator (S-ICD) System

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 27, 2009
Last Updated
July 1, 2021
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00853645
Brief Title
Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
Acronym
Chronic II
Official Title
Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 2008 (Actual)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachyarrhythmias

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subcutaneous implantable cardioverter defibrillator (S-ICD) System
Arm Type
Experimental
Arm Description
Single-arm with 6 patients implanted with an S-ICD System
Intervention Type
Device
Intervention Name(s)
Subcutaneous Implantable Defibrillator (S-ICD) System
Primary Outcome Measure Information:
Title
Number of Participants With a Successful Induced Ventricular Fibrillation Conversion
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen O'Connor, PhD, Hon FRACP
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1001
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8140
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
20463331
Citation
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.
Results Reference
derived

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Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System

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