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SAFEty of Two Strategies of ICD Management at Implantation (SAFE-ICD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00661037
First received: April 7, 2008
Last updated: June 22, 2017
Last verified: June 2017
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: SAFEty of Two Strategies of ICD Management at Implantation

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up [ Time Frame: 2 years ]
    • Severe implant-related* complications at ICD implants among the following:

      • Survival from cardiopulmonary arrest due to VF requiring 3 or more consecutive external shocks for termination or due to electro-mechanical dissociation.
      • Transient ischemic attack or stroke,
      • Cardiogenic shock,
      • Pulmonary edema,
      • Embolic events,
      • Anoxic coma
      • Pericardial tamponade
      • Death.
    • Events at follow up:

      • Sudden cardiac death (defined as witnessed unexpected death occurring <1 hour from symptoms onset or unwitnessed during sleep)
      • Resuscitation after ineffective documented appropriate ICD shocks

        • Implant related events are considered as those listed above, occurring during the implant procedure in the timeframe betweend device poket insertion and patient exit from the cath-lab, as well as those events occurring after the patient exit from the cath-lab that, after review from the event adjudication committee, have been classified as related to the implant procedure.


Secondary Outcome Measures:
  • Severe Intra-operative Complications [ Time Frame: Acute (ICD implant) ]
    including: cardiopulmonary arrest, transient ischemic attack or stroke, cardiogenic shock, pulmonary edema, embolic event, anoxic coma, pericardial tamponade,death

  • Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up [ Time Frame: 2 years ]

Enrollment: 2120
Study Start Date: March 2008
Study Completion Date: September 2011
Primary Completion Date: May 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.
Other Name: Not applicable. All devices allowed.
2
Patients not having VF induction at implant or during follow-up
Device: Implantable defibrillator
Implantable defibrillator to reduce ventricular arrhythmias via shock.
Other Name: Not applicable. All devices allowed.

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Italy
Ospedali del Tigullio, via Don Bobbio 25
Lavagna, Italy, 16033
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Chair: Michele Brignole, MD Ospedali del Tigullio
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00661037     History of Changes
Other Study ID Numbers: 2007_SI
Study First Received: April 7, 2008
Results First Received: February 20, 2017
Last Updated: June 22, 2017

Additional relevant MeSH terms:
Death
Death, Sudden, Cardiac
Ventricular Fibrillation
Ventricular Flutter
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on September 21, 2017