Comparison · NCT01898221-sae
Standard Catheter Ablation Patient Group vs Vein of Marshall and Standar Procedure: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Standard Catheter Ablation Patient Group vs Vein of Marshall and Standar Procedure: serious adverse events. Trial comparisons, record NCT01898221-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01898221-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 | 0.184 | 0.131 | 0.251 | wilson | |
| Risk in group 2 | 0.205 | 0.153 | 0.269 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0219 | -0.105 | 0.0634 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.894 | 0.579 | 1.38 | log | |
| Odds ratio, group 1 over group 2 | 0.87 | 0.508 | 1.49 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Standard Catheter Ablation Patient Group than on Vein of Marshall and Standar Procedure | 45.7 | 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 | Standard Catheter Ablation Patient Group | Patients will have a standard procedure ablation~Ablation: The doctor will perform only the standard procedure. Throughout the procedure, the researchers will document the following information for ALL patients: measurements such as whether the treatment was successful or unsuccessful, X-ray exposure time, procedure time, whether there were any complications, and other general procedural measurements. | 29 | 158 | EG000 |
| Group 2 | Vein of Marshall and Standar Procedure | The doctor will inject Ethanol through a balloon catheter into the VOM~Ethanol: We enter the CS with a sheath advanced from the right internal jugular vein. A sub-selector catheter with a \~90° angle at the tip (typically, a left internal mammary artery angioplasty guide catheter) is advanced through the CS sheath with its tip pointing superiorly and posteriorly. | 38 | 185 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- AE data collected for 1 year post ablation. This was FU period for patients enrolled in the trial.
Source ClinicalTrials.gov
Trial
- Title
- Vein of Marshall Ethanol Infusion for Persistent Atrial Fibrillation
- NCT number
- NCT01898221
- Phases
- PHASE3
- Conditions
- Ventricular Tachycardia, Atrial Fibrillation
- Interventions
- Ethanol, Ablation
- Lead sponsor
- The Methodist Hospital Research Institute
- Results first posted
- 2025-08-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01898221?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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