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OpenTrials
Completed

NCT Number: NCT00661037

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

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Key information

Conditions

Ventricular Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Death Ventricular Flutter

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedali del Tigullio, via Don Bobbio 25

Lavagna, 16033, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implantable defibrillator

Device

Implantable defibrillator to reduce ventricular arrhythmias via shock.

Other names: Not applicable. All devices allowed.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: SAFE-ICD

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Apr 18, 2008
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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