Comparison · NCT00800384-sae
ICD Implant Without Defibrillation Testing vs ICD Implant With Defibrillation Testing: serious adverse events
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. ICD Implant Without Defibrillation Testing vs ICD Implant With Defibrillation Testing: serious adverse events. Trial comparisons, record NCT00800384-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00800384-sae
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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 | 0.622 | 0.595 | 0.649 | wilson | |
| Risk in group 2 | 0.63 | 0.603 | 0.657 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00819 | -0.0461 | 0.0297 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.987 | 0.929 | 1.05 | log | |
| Odds ratio, group 1 over group 2 | 0.966 | 0.821 | 1.14 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on ICD Implant Without Defibrillation Testing than on ICD Implant With Defibrillation Testing | 122 | 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 | ICD Implant Without Defibrillation Testing | Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed. | 776 | 1,247 | EG000 |
| Group 2 | ICD Implant With Defibrillation Testing | Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant. | 790 | 1,253 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
Source ClinicalTrials.gov
Trial
- Title
- Shockless Implant Evaluation
- NCT number
- NCT00800384
- Phases
- NA
- Conditions
- Ventricular Fibrillation, Ventricular Tachycardia
- Interventions
- Implantable defibrillator
- Lead sponsor
- Boston Scientific Corporation
- Results first posted
- 2015-12-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00800384?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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