Trial Outcomes & Findings for SAFEty of Two Strategies of ICD Management at Implantation (NCT NCT00661037)

NCT ID: NCT00661037

Last Updated: 2017-07-21

Results Overview

* 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.

• Recruitment status: COMPLETED
• Target enrollment: 2120 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2017-07-21

Participant Flow

Participant milestones

Measure	VF Induction Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)	no VF Induction Patients not having VF induction at implant or during follow-up Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock.
Overall Study STARTED	836	1284
Overall Study Witdrawn	47	68
Overall Study Deaths	108	188
Overall Study COMPLETED	682	1027
Overall Study NOT COMPLETED	154	257

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SAFEty of Two Strategies of ICD Management at Implantation

Baseline characteristics by cohort

Measure	VF Induction n=836 Participants Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)	no VF Induction n=1284 Participants Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)	Total n=2120 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 12 • n=5 Participants	67 years STANDARD_DEVIATION 11 • n=7 Participants	66 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	152 Participants n=5 Participants	268 Participants n=7 Participants	420 Participants n=5 Participants
Sex: Female, Male Male	684 Participants n=5 Participants	1016 Participants n=7 Participants	1700 Participants n=5 Participants
Region of Enrollment Italy	836 participants n=5 Participants	1284 participants n=7 Participants	2120 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	VF Induction n=836 Participants Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)	no VF Induction n=1284 Participants Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up	18 Participants	16 Participants

SECONDARY outcome

Timeframe: Acute (ICD implant)

including: cardiopulmonary arrest, transient ischemic attack or stroke, cardiogenic shock, pulmonary edema, embolic event, anoxic coma, pericardial tamponade,death

Outcome measures

Measure	VF Induction n=836 Participants Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)	no VF Induction n=1284 Participants Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
Severe Intra-operative Complications	8 Participants	4 Participants

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Measure	VF Induction n=836 Participants Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)	no VF Induction n=1284 Participants Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up	10 Participants	12 Participants

Adverse Events

VF Induction

Serious events: 209 serious events

Other events: 120 other events

Deaths: 108 deaths

no VF Induction

Serious events: 177 serious events

Other events: 90 other events

Deaths: 188 deaths

Serious adverse events

Measure	VF Induction n=836 participants at risk Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)	no VF Induction n=1284 participants at risk Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
Cardiac disorders SAE-serious adverse events	17.5% 146/836 • Number of events 222 • 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)	10.4% 133/1284 • Number of events 205 • 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)
Cardiac disorders SADE - serious adverse device effects	7.5% 63/836 • Number of events 107 • 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)	3.4% 44/1284 • Number of events 74 • 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)

Other adverse events

Measure	VF Induction n=836 participants at risk Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)	no VF Induction n=1284 participants at risk Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
Cardiac disorders AE - Adverse Events (Non serious / non device related)	5.0% 42/836 • Number of events 53 • 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)	3.4% 44/1284 • Number of events 53 • 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)
Cardiac disorders ADE - non serious adverse device effects	9.3% 78/836 • Number of events 126 • 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)	3.6% 46/1284 • Number of events 70 • 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)

Additional Information

Dr Michele Brignole

Ospedali del Tigullio, Lavagna, Italy

Phone: 0185 329567329

Email: aritmo@asl4.liguria.it

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place