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
1 other identifier
observational
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 10, 2006
CompletedFirst Posted
Study publicly available on registry
November 14, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFebruary 16, 2017
May 1, 2010
1.6 years
November 10, 2006
February 14, 2017
Conditions
Keywords
Interventions
Eligibility Criteria
patients requiring ICD therapy
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Papworth Hospital NHS Trust
Papworth Everard, Cambridge, CB3 8RE, United Kingdom
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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew A Grace, MD, PhD
Papworth Hospital NHS Foundation Trust
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2006
First Posted
November 14, 2006
Study Start
November 1, 2006
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
February 16, 2017
Record last verified: 2010-05