NCT00399217

Further Acute Research of a Subcutaneous Implantable Defibrillator (S-ICD) System

Acute Intra-operative Testing of Subcutaneous Implantable Defibrillator Emulator and Parasternal Electrode, Acutely Implanted, for Comparison With Transvenous System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 55 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose is to further evaluate the operation, safety, and feasibility of a subcutaneous implantable defibrillator (S-ICD) system in patients who require an implantable cardioverter defibrillator (ICD)for treating ventricular tachyarrhythmias. The S-ICD electrode and pulse generator emulator will be briefly implanted and tested during the standard implantation procedure of an ICD, but then the S-ICD system will be removed entirely.

Detailed description

The objectives of this study are to further evaluate the S-ICD system's ability to identify and terminate induced ventricular tachyarrhythmias in patients acutely with an S-ICD emulator and parasternal electrode during the implant procedure of a standard transvenous ICD. The active emulator is not a powered medical device and all elements of the test system are removed following the testing. This acute intra-operative protocol will test the ability of the electrode and emulator to appropriately convert the arrhythmia and allos an assessment of post shock pacing.

Conditions

• Ventricular Fibrillation
• Ventricular Tachycardia

Interventions

Type	Name	Description
DEVICE	Subcutaneous Implantable Defibrillator (S-ICD) system
DEVICE	ICD

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2006-11-14
• Last updated: 2017-02-16

Locations

1 site across 1 country: United Kingdom