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SAFEty of Two Strategies of ICD Management at Implantation (SAFE-ICD)
This study is currently recruiting participants.
Verified by Guidant Corporation, April 2008
Sponsored by: Guidant Corporation
Information provided by: Guidant Corporation
ClinicalTrials.gov Identifier: NCT00661037
  Purpose

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

Genetics Home Reference related topics: Brugada syndrome short QT syndrome
MedlinePlus related topics: Cardiac Arrest Pacemakers and Implantable Defibrillators
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: SAFEty of Two Strategies of ICD Management at Implantation

Further study details as provided by Guidant Corporation:

Primary Outcome Measures:
  • composite of: 1) severe intra-operative complications at ICD implant 2) events at follow up [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Severe intra-operative complications or occurring as consequence of defibrillation test; total mortality; survival to ineffective appropriate ICD shocks without resuscitation maneuvers; [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Biospecimen Description:

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
1
Patients having VF induction with shock termination at implant
Device: Implantable defibrillator
Implantable defibrillator to reduce ventricular arrhythmias via shock.
2
Patients not having VF induction at implant or during follow-up
Device: Implantable defibrillator
Implantable defibrillator to reduce ventricular arrhythmias via shock.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients having the risk of life threatening arrhythmias and indicated for the implant of an implantable cardioverter defibrillator.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661037

Contacts
Contact: Francesco Accardi +39-02-269832 francesco.accardi@bsci.com
Contact: Giovanni Raciti +39-02-26983213 giovanni.raciti@bsci.com

Locations
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            
Sponsors and Collaborators
Guidant Corporation
Investigators
Study Chair: Michele Brignole, MD Ospedali del Tigullio
  More Information

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

Study placed in the following topic categories:
Death
Heart Diseases
Death, Sudden
Paroxysmal ventricular fibrillation
Heart Arrest
Death, Sudden, Cardiac
Ventricular Flutter
Ventricular Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009