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Sponsored by: |
Guidant Corporation |
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Information provided by: | Guidant Corporation |
ClinicalTrials.gov Identifier: | NCT00661037 |
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
Condition | Intervention |
---|---|
Ventricular Fibrillation Ventricular Flutter Sudden Cardiac Death |
Device: Implantable defibrillator |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | SAFEty of Two Strategies of ICD Management at Implantation |
Estimated Enrollment: | 1568 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Patients having VF induction with shock termination at implant
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Device: Implantable defibrillator
Implantable defibrillator to reduce ventricular arrhythmias via shock.
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2
Patients not having VF induction at implant or during follow-up
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Device: Implantable defibrillator
Implantable defibrillator to reduce ventricular arrhythmias via shock.
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The standardized requirements for implantable cardioverter defibrillator (ICD) include defibrillation testing (DT), consisting in induction and termination of ventricular fibrillation (VF). An effective DT has historically been considered part of standard procedures at implant. Nevertheless, implant techniques and technology have evolved during years and nowadays deviations are frequent in clinical practice mainly due to the fact that physicians are seriously concerned about the risk of severe complications related to DT. However, the practice of not performing DT is arbitrary and its safety is yet unproven. This observational study will assess the safety of the two strategies adopted at ICD implant: induction (including patients who undergo DT at implant) and non-induction (including patients who do not undergo DT at implant. No deviation from the centres' current practice in choosing to perform or not perform DT is introduced by this study protocol. The study considers consecutive patients undergoing first implant of ICD
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
All patients having the risk of life threatening arrhythmias and indicated for the implant of an implantable cardioverter defibrillator.
Inclusion Criteria:
Exclusion Criteria:
Contact: Francesco Accardi | +39-02-269832 | francesco.accardi@bsci.com |
Contact: Giovanni Raciti | +39-02-26983213 | giovanni.raciti@bsci.com |
Italy | |
Ospedali del Tigullio, via Don Bobbio 25 | Recruiting |
Lavagna, Italy, 16033 | |
Contact: Michele Brignole, MD +39-0185-329569 mbrignole@ASL4.LIGURIA.IT | |
Contact: Eraldo Occhetta, MD +39-0321-3733413 eraldo.occhetta@maggioreosp.novara.it | |
Principal Investigator: Michele Brignole, MD | |
Sub-Investigator: Eraldo Occhetta, MD |
Study Chair: | Michele Brignole, MD | Ospedali del Tigullio |
Responsible Party: | Ospedali del Tigullio, via Don Bobbio 25 16033, Lavagna (GE), Italy ( Principal Investigator,Michele Brignole, MD ) |
Study ID Numbers: | 2007_SI |
Study First Received: | April 7, 2008 |
Last Updated: | April 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00661037 |
Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Death Heart Diseases Death, Sudden Paroxysmal ventricular fibrillation Heart Arrest |
Death, Sudden, Cardiac Ventricular Flutter Ventricular Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |