Trial · NCT00661037
SAFEty of Two Strategies of ICD Management at Implantation
NCT00661037, Completed, Boston Scientific Corporation; results first posted 2017-06-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SAFEty of Two Strategies of ICD Management at Implantation. Trials, record NCT00661037. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00661037
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SAFEty of Two Strategies of ICD Management at Implantation
- NCT number
- NCT00661037
- Status
- Completed
- Enrollment
- 2,120 participants, actual
- Lead sponsor
- Boston Scientific Corporation
- Conditions
- Ventricular Fibrillation, Ventricular Flutter, Sudden Cardiac Death
- Interventions
- Implantable defibrillator, Implantable defibrillator
- First posted
- 2008-04-18
- Last updated
- 2017-07-21
- Results first posted
- 2017-06-20
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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 |
| Secondary | Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up | 2 years |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Severe Intra-operative Complications | Acute (ICD implant) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up | 2 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up | VF Induction | 18 | Participants | ||
| Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up | no VF Induction | 16 | Participants | ||
| Severe Intra-operative Complications | VF Induction | 8 | Participants | ||
| Severe Intra-operative Complications | no VF Induction | 4 | Participants | ||
| Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up | VF Induction | 10 | Participants | ||
| Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up | No- VF Induction | 12 | Participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | VF Induction | 836 | |
| Overall Study | STARTED | no VF Induction | 1,284 | |
| Overall Study | Witdrawn | VF Induction | 47 | |
| Overall Study | Witdrawn | no VF Induction | 68 | |
| Overall Study | Deaths | VF Induction | 108 | |
| Overall Study | Deaths | no VF Induction | 188 | |
| Overall Study | COMPLETED | VF Induction | 682 | |
| Overall Study | COMPLETED | no VF Induction | 1,027 | |
| Overall Study | NOT COMPLETED | VF Induction | 154 | |
| Overall Study | NOT COMPLETED | no VF Induction | 257 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | AE - Adverse Events (Non serious / non device related) | Cardiac disorders | VF Induction | 42 | 836 | 53 |
| other | AE - Adverse Events (Non serious / non device related) | Cardiac disorders | no VF Induction | 44 | 1,284 | 53 |
| other | ADE - non serious adverse device effects | Cardiac disorders | VF Induction | 78 | 836 | 126 |
| other | ADE - non serious adverse device effects | Cardiac disorders | no VF Induction | 46 | 1,284 | 70 |
| serious | SAE-serious adverse events | Cardiac disorders | VF Induction | 146 | 836 | 222 |
| serious | SAE-serious adverse events | Cardiac disorders | no VF Induction | 133 | 1,284 | 205 |
| serious | SADE - serious adverse device effects | Cardiac disorders | VF Induction | 63 | 836 | 107 |
| serious | SADE - serious adverse device effects | Cardiac disorders | no VF Induction | 44 | 1,284 | 74 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | VF Induction | 108 | 836 |
| Total, all-cause mortality | no VF Induction | 188 | 1,284 |
| Total, other adverse events | VF Induction | 120 | 836 |
| Total, other adverse events | no VF Induction | 90 | 1,284 |
| Total, serious adverse events | VF Induction | 209 | 836 |
| Total, serious adverse events | no VF Induction | 177 | 1,284 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22858384 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| VF Induction vs No- VF Induction: Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up | Trial comparisons |
| VF Induction vs no VF Induction: Severe Intra-operative Complications | Trial comparisons |
| VF Induction vs no VF Induction: deaths from any cause | Trial comparisons |
| VF Induction vs no VF Induction: Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up | Trial comparisons |
| VF Induction vs no VF Induction: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00661037
GET https://conductscience.org/api/trials/v1/NCT00661037/registered