SAFE-ICD: SAFEty of Two Strategies of ICD Management at Implantation

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00661037
• Collaborator: (none)
• Enrollment: 2,120
• Location: 1
• Duration (Months): 42
• Patients Per Site Per Month: 50.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ventricular Fibrillation; Ventricular Flutter; Sudden Cardiac Death	Device: Implantable defibrillator; 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 Design

• Study Type: Observational
• Actual Enrollment: 2120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: SAFEty of Two Strategies of ICD Management at Implantation
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up [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 Outcome Measures

1. Severe Intra-operative Complications [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 [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedali del Tigullio, via Don Bobbio 25	Lavagna		Italy	16033

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Study Chair: Michele Brignole, MD, Ospedali del Tigullio

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT00661037
• Other Study ID Numbers: 2007_SI
• First Posted: Apr 18, 2008
• Last Update Posted: Jul 21, 2017
• Last Verified: Jun 1, 2017

• Additional relevant MeSH terms: Death, Sudden, Cardiac; Ventricular Fibrillation; Ventricular Flutter; Death

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	VF Induction	no VF Induction	Total
Arm/Group Description	Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)	Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)	Total of all reporting groups
Overall Participants	836	1284	2120
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66 (12)	67 (11)	66 (11)
Sex: Female, Male (Count of Participants)
Female	152 18.2%	268 20.9%	420 19.8%
Male	684 81.8%	1016 79.1%	1700 80.2%
Region of Enrollment (participants) [Number]
Italy	836 100%	1284 100%	2120 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up
Description	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.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VF Induction	no VF Induction
Arm/Group Description	Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)	Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
Measure Participants	836	1284
Count of Participants [Participants]	18 2.2%	16 1.2%

2. Secondary Outcome

Title	Severe Intra-operative Complications
Description	including: cardiopulmonary arrest, transient ischemic attack or stroke, cardiogenic shock, pulmonary edema, embolic event, anoxic coma, pericardial tamponade,death
Time Frame	Acute (ICD implant)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VF Induction	no VF Induction
Arm/Group Description	Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)	Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
Measure Participants	836	1284
Count of Participants [Participants]	8 1%	4 0.3%

3. Secondary Outcome

Title	Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VF Induction	No- VF Induction
Arm/Group Description	Patients having VF induction with shock termination at implant	Patients not having VF induction at implant or during follow-up
Measure Participants	836	1284
Count of Participants [Participants]	10 1.2%	12 0.9%

Adverse Events

Time Frame	2 years
Adverse Event Reporting Description	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)
Arm/Group Title	VF Induction		no VF Induction
Arm/Group Description	Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)		Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
All Cause Mortality
	VF Induction		no VF Induction
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	108/836 (12.9%)		188/1284 (14.6%)
Serious Adverse Events
	VF Induction		no VF Induction
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	209/836 (25%)		177/1284 (13.8%)
Cardiac disorders
SAE-serious adverse events	146/836 (17.5%)	222	133/1284 (10.4%)	205
SADE - serious adverse device effects	63/836 (7.5%)	107	44/1284 (3.4%)	74
Other (Not Including Serious) Adverse Events
	VF Induction		no VF Induction
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	120/836 (14.4%)		90/1284 (7%)
Cardiac disorders
AE - Adverse Events (Non serious / non device related)	42/836 (5%)	53	44/1284 (3.4%)	53
ADE - non serious adverse device effects	78/836 (9.3%)	126	46/1284 (3.6%)	70

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.