Comparison · NCT02235545-sae
Right Ventricle Lead-Related Complications vs Summary of System and/or Procedure Related Complications Not Related to the RV Lead.: 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. Right Ventricle Lead-Related Complications vs Summary of System and/or Procedure Related Complications Not Related to the RV Lead.: serious adverse events. Trial comparisons, record NCT02235545-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02235545-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 | 0.0334 | 0.0259 | 0.043 | wilson | |
| Risk in group 2 | 0.0772 | 0.0656 | 0.0907 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0438 | -0.0593 | -0.0287 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.433 | 0.32 | 0.585 | log | |
| Odds ratio, group 1 over group 2 | 0.413 | 0.301 | 0.567 | log | |
Number needed to treat, for one fewer participant with a serious adverse event on Right Ventricle Lead-Related Complications than on Summary of System and/or Procedure Related Complications Not Related to the RV Lead. | 22.8 | 16.9 | 34.8 | from the risk difference interval |
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 | Right Ventricle Lead-Related Complications | Summary of RV Lead-Related Complications. A complication is an adverse event caused by or associated with the study device, system component(s), and or procedure that requires invasive intervention (e.g. lead dislodgement requiring repositioning) including RV lead perforations. All RV lead perforations will be reported as complications. | 58 | 1,735 | EG000 |
| Group 2 | Summary of System and/or Procedure Related Complications Not Related to the RV Lead. | Summary of System and/or Procedure Related Complications not related to the RV lead. Includes both System/Pule Generator/Lead Related (RA/LV) and Procedure Related Only | 134 | 1,735 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 5 years from baseline for each participant
Source ClinicalTrials.gov
Trial
- Title
- Optisure Lead Post Approval Study
- NCT number
- NCT02235545
- Phases
- Conditions
- Heart Failure, Tachycardia, Ventricular
- Interventions
- St. Jude Medical Optisure Lead
- Lead sponsor
- Abbott Medical Devices
- Results first posted
- 2025-07-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02235545?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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