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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients having VF induction with shock termination at implant |
| |
| 2 | Patients not having VF induction at implant or during follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable defibrillator | Device | Implantable defibrillator to reduce ventricular arrhythmias via shock. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up |
| 2 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients having the risk of life threatening arrhythmias and indicated for the implant of an implantable cardioverter defibrillator.
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| Name | Affiliation | Role |
|---|---|---|
| Michele Brignole, MD | Ospedali del Tigullio | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedali del Tigullio, via Don Bobbio 25 | Lavagna | 16033 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22858384 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | VF Induction | Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock) |
| FG001 | no VF Induction | Patients not having VF induction at implant or during follow-up Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VF Induction | Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock) |
| BG001 | no VF Induction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up |
| Posted | Count of Participants | Participants | 2 years |
|
2 years
Adverse Events were assessed without regard to the specific Adverse Event Terms but classified withing the boundaries of ISO classfication: Adverse Event (AE); Adverse Device Effect (ADE); Serious Adverse Event (SAE): Serious Adverse Device Effect (SADE)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VF Induction | Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SAE-serious adverse events | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AE - Adverse Events (Non serious / non device related) | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Michele Brignole | Ospedali del Tigullio, Lavagna, Italy | 0185 329567329 | 0039 | aritmo@asl4.liguria.it |
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| ID | Term |
|---|---|
| D014693 | Ventricular Fibrillation |
| D054141 | Ventricular Flutter |
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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| Implantable defibrillator | Device | Implantable defibrillator to reduce ventricular arrhythmias via shock. |
|
|
| 2 years |
Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | VF Induction | Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock) |
| OG001 | no VF Induction | Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock) |
|
|
| Secondary | Severe Intra-operative Complications | including: cardiopulmonary arrest, transient ischemic attack or stroke, cardiogenic shock, pulmonary edema, embolic event, anoxic coma, pericardial tamponade,death | Posted | Count of Participants | Participants | Acute (ICD implant) |
|
|
|
| Secondary | Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up | Posted | Count of Participants | Participants | 2 years |
|
|
|
| 108 |
| 836 |
| 209 |
| 836 |
| 120 |
| 836 |
| EG001 | no VF Induction | Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock) | 188 | 1,284 | 177 | 1,284 | 90 | 1,284 |
| SADE - serious adverse device effects | Cardiac disorders |
|
| ADE - non serious adverse device effects | Cardiac disorders |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
| D003643 | Death |
| D004567 |
| Electrodes, Implanted |
| D019736 | Prostheses and Implants |