Sudden Cardiac Death Clinical Trial
— SAFE-ICDOfficial title:
SAFEty of Two Strategies of ICD Management at Implantation
The aim of this prospective observational study is to evaluate the safety, over a follow-up of 2 years, of two strategies, consisting in performing or not performing defibrillation testing(DT) during first implant of implantable cardioverter defibrillator
Status | Completed |
Enrollment | 2130 |
Est. completion date | September 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - first implantation of ICD or CRT-D - Patients undergoing upgrade to ICD or CRT-D from pacemaker - Patients undergoing upgrade to CRT-D from CRT - Age 18 or above, or legal age to give written informed consent Exclusion Criteria: - Patients who do not give consent to treat their data. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Italy | Ospedali del Tigullio, via Don Bobbio 25 | Lavagna |
Lead Sponsor | Collaborator |
---|---|
Guidant Corporation |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | composite of: 1) severe intra-operative complications at ICD implant 2) events at follow up | 2 years | Yes | |
Secondary | Severe intra-operative complications or occurring as consequence of defibrillation test; total mortality; survival to ineffective appropriate ICD shocks without resuscitation maneuvers; | 2 years | Yes |
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