Comparison · NCT00661037-f4af99b7
VF Induction vs no VF Induction: Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. 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, record NCT00661037-f4af99b7. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00661037-f4af99b7
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0215 | 0.0137 | 0.0338 | wilson | |
| Risk in group 2 | 0.0125 | 0.00768 | 0.0201 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00907 | -0.00193 | 0.0222 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.73 | 0.886 | 3.37 | log | |
| Odds ratio, group 1 over group 2 | 1.74 | 0.884 | 3.44 | log | |
| Number needed to treat, for one more participant with the outcome on VF Induction than on no VF Induction | 110 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | VF Induction | Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock) | 18 | 836 | OG000 |
| Group 2 | no VF Induction | Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock) | 16 | 1,284 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- 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
- Population
Source ClinicalTrials.gov
Trial
- Title
- SAFEty of Two Strategies of ICD Management at Implantation
- NCT number
- NCT00661037
- Phases
- Conditions
- Ventricular Fibrillation, Ventricular Flutter, Sudden Cardiac Death
- Interventions
- Implantable defibrillator, Implantable defibrillator
- Lead sponsor
- Boston Scientific Corporation
- Results first posted
- 2017-06-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00661037?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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