SAFEty of Two Strategies of ICD Management at Implantation

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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SAFEty of Two Strategies of ICD Management at Implantation

Conditions
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Ventricular Fibrillation, Ventricular Flutter, Sudden Cardiac Death

Intervention / Treatment
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* Device: Implantable defibrillator
* Device: Implantable defibrillator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients having VF induction with shock termination at implant | Device: Implantable defibrillator<br>* Implantable defibrillator to reduce ventricular arrhythmias via shock.<br>* Other names: Not applicable. All devices allowed.;|
| 2<br>Patients not having VF induction at implant or during follow-up | Device: Implantable defibrillator<br>* Implantable defibrillator to reduce ventricular arrhythmias via shock.<br>* Other names: Not applicable. All devices allowed.;|

What is the study measuring?
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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 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. | 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 |