Comparison · NCT00800384-e0744846
ICD Implant Without Defibrillation Testing vs ICD Implant With Defibrillation Testing: First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death
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: First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death. Trial comparisons, record NCT00800384-e0744846. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00800384-e0744846
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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 | 0.0722 | 0.0591 | 0.0879 | wilson | |
| Risk in group 2 | 0.083 | 0.069 | 0.0996 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0108 | -0.032 | 0.0102 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.87 | 0.663 | 1.14 | log | |
| Odds ratio, group 1 over group 2 | 0.859 | 0.641 | 1.15 | log | |
| Number needed to treat, for one fewer participant with the outcome on ICD Implant Without Defibrillation Testing than on ICD Implant With Defibrillation Testing | 92.4 | 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. | 90 | 1,247 | OG000 |
| 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. | 104 | 1,253 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death
- Description
- The number of patients having experienced either an appropriate inefficient shock and/or arrhythmic death during the follow-up time frame of 3.1 years is compared between both groups.
- Time frame
- Mean follow-up of 3.1 years
- Population
All patients were analyzed as per intention to treat. An on treatment analysis was performed in 1190 patients in the group without defibrillation testing and in 1165 patients in the group with defibrillation testing.
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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