Clinical trial NCT00399217: Further Acute Research of a Subcutaneous Implantable Defibrillator (S-ICD) System
Official title: Acute Intra-operative Testing of Subcutaneous Implantable Defibrillator Emulator and Parasternal Electrode, Acutely Implanted, for Comparison With Transvenous System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Fibrillation
Ventricular Tachycardia
Keywords: subcutaneous ICD
ICD
DFT
Pacing threshold
Polarity
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2006-11-14
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients requiring ICD therapy

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients requiring ICD therapy according to National Centre for Clinical Excellence (NICE) criteria are eligible
* And patients who require replacement of an existing transvenous ICD system are eligible

Exclusion Criteria:

* Patients unable or unwilling to provide informed consent
* Any conditions which precludes the subject's ability to comply with the study requirements, including completion of the study
* 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 this study
* 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Papworth Everard
country: United Kingdom
facility: Papworth Hospital NHS Trust
state: Cambridge
Study officials:
affiliation: Papworth Hospital NHS Foundation Trust
name: Andrew A Grace, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.