Ventricular FibrillationSAFE-ICDNCT00661037
SAFEty of Two Strategies of ICD Management at Implantation
An observational study of Ventricular Fibrillation and Ventricular Flutter, run by Boston Scientific Corporation at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Fibrillation, Ventricular Flutter, Sudden Cardiac Death
- What is being tested?
- Implantable defibrillator
- Type of treatment
- Medical device
- How many people
- 2,120 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2008to Sep 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients having the risk of life threatening arrhythmias and indicated for the implant of an implantable cardioverter defibrillator.
Who may be able to join
- 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
Who cannot join
- Patients who do not give consent to treat their data.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Being tested
- Implantable defibrillator
- Medical subject headings
- Ventricular Fibrillation, Ventricular Flutter, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable defibrillatorDevice
Also called Not applicable. All devices allowed.
Implantable defibrillator to reduce ventricular arrhythmias via shock.
Implantable defibrillatorDevice
Also called Not applicable. All devices allowed.
Implantable defibrillator to reduce ventricular arrhythmias via shock.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients having VF induction with shock termination at implant Receives: Device: Implantable defibrillator | |
| 2 | Patients not having VF induction at implant or during follow-up Receives: Device: Implantable defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
Severe Intra-operative Complications
including: cardiopulmonary arrest, transient ischemic attack or stroke, cardiogenic shock, pulmonary edema, embolic event, anoxic coma, pericardial tamponade,death
Measured: Acute (ICD implant)
Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michele Brignole, MD, Study chair, Ospedali del Tigullio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661037
- Sponsor's protocol ID
- 2007_SI
- Acronym
- SAFE-ICD
- Status last verified
- Jun 2017
- First submitted
- 7 Apr 2008
- Last updated
- 21 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 22858384
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAFEty of Two Strategies of ICD Management at Implantation
- ClinicalTrials.gov ID
- NCT00661037
- Acronym / sponsor ID
- SAFE-ICD / 2007_SI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,120 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 18 Apr 2008 (estimated)
- Results
- Posted 20 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Implantable defibrillatorPatients having VF induction with shock termination at implant |
| 2 | – | Device: Implantable defibrillatorPatients not having VF induction at implant or during follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients having the risk of life threatening arrhythmias and indicated for the implant of an implantable cardioverter defibrillator.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who do not give consent to treat their data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable defibrillatorAlso: Not applicable. All devices allowed.Implantable defibrillator to reduce ventricular arrhythmias via shock. | Device | 1 |
| Implantable defibrillatorAlso: Not applicable. All devices allowed.Implantable defibrillator to reduce ventricular arrhythmias via shock. | Device | 2 |
Primary outcome
Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up
Time frame: 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.
2 secondary outcomes
Severe Intra-operative Complications
Time frame: Acute (ICD implant)
Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22858384Brignole 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.
Related trials for Ventricular Fibrillation
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Heart Failure, Atrial Fibrillation (AF)
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Recruiting
Bundle Branch Pacing to Preserve Ejection Fraction in Atrial Fibrillation Trial
Permanent Atrial Fibrillation, Preserved Ejection Fraction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Brignole, MD study chair
Ospedali del Tigullio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Fibrillation and Ventricular Flutter, run by Boston Scientific Corporation at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00661037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.