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

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

Study Overview

• Status: Completed
• Conditions: Ventricular Fibrillation; Sudden Cardiac Death; Ventricular Flutter
• Intervention / Treatment: Device: Implantable defibrillator

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

• Study Type: Observational
• Enrollment (Actual): 2120

Contacts and Locations

Study Locations

• Italy
  • Lavagna, Italy, 16033
    • Ospedali del Tigullio, via Don Bobbio 25

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Patients having VF induction with shock termination at implant	Device: Implantable defibrillator; Implantable defibrillator to reduce ventricular arrhythmias via shock.; Other Names: 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 Names: Not applicable. All devices allowed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up	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 comaPericardial tamponadeDeath.; 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 shocksImplant 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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe Intra-operative Complications	including: cardiopulmonary arrest, transient ischemic attack or stroke, cardiogenic shock, pulmonary edema, embolic event, anoxic coma, pericardial tamponade,death	Acute (ICD implant)
Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up		2 years

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Chair: Michele Brignole, MD, Ospedali del Tigullio

Publications and helpful links

General Publications

• Brignole M, Occhetta E, Bongiorni MG, Proclemer A, Favale S, Iacopino S, Calo L, Vado A, Buja G, Mascioli G, Quartieri F, Tritto M, Parravicini U, Castro A, Tomasi C, Villani GQ, D'Acri MG, Klersy C, Gasparini M; SAFE-ICD Study Investigators. Clinical evaluation of defibrillation testing in an unselected population of 2,120 consecutive patients undergoing first implantable cardioverter-defibrillator implant. J Am Coll Cardiol. 2012 Sep 11;60(11):981-7. doi: 10.1016/j.jacc.2012.05.014. Epub 2012 Aug 1.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: April 7, 2008
• First Submitted That Met QC Criteria: April 17, 2008
• First Posted (Estimate): April 18, 2008

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: June 22, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Arrhythmias, Cardiac; Heart Arrest; Death; Ventricular Fibrillation; Death, Sudden, Cardiac; Ventricular Flutter
• Other Study ID Numbers: 2007_SI