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

Ventricular Tachyarrhythmias Clinical Trial

— Chronic II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00853645
• Other study ID #: DN-11398
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Est. completion date: September 2008

Study information

• Verified date: July 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachyarrhythmias

Intervention

Device:
• Subcutaneous Implantable Defibrillator (S-ICD) System

Locations

Country	Name	City	State
New Zealand	Auckland City Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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