Comparison · NCT01898221-c6677ebe
Standard Catheter Ablation Patient Group vs Vein of Marshall and Standar Procedure: Amount of Treated Subjects With Freedom of Symptomatic Post-procedural AF or Flutter at 12 and 15 Months Post Procedure and Less Than 1 Min/Day of AF or Flutter on 4-week EKG Monitor.
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. Standard Catheter Ablation Patient Group vs Vein of Marshall and Standar Procedure: Amount of Treated Subjects With Freedom of Symptomatic Post-procedural AF or Flutter at 12 and 15 Months Post Procedure and Less Than 1 Min/Day of AF or Flutter on 4-week EKG Monitor. Trial comparisons, record NCT01898221-c6677ebe. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01898221-c6677ebe
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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 | 0.38 | 0.308 | 0.457 | wilson | |
| Risk in group 2 | 0.492 | 0.421 | 0.563 | wilson | |
| Risk difference, group 1 minus group 2 | -0.112 | -0.214 | -0.00681 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.772 | 0.603 | 0.989 | log | |
| Odds ratio, group 1 over group 2 | 0.632 | 0.411 | 0.974 | log | |
| Number needed to treat, for one fewer participant with the outcome on Standard Catheter Ablation Patient Group than on Vein of Marshall and Standar Procedure | 8.92 | 4.68 | 147 | 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 | 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. | 60 | 158 | OG000 |
| 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. | 91 | 185 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Amount of Treated Subjects With Freedom of Symptomatic Post-procedural AF or Flutter at 12 and 15 Months Post Procedure and Less Than 1 Min/Day of AF or Flutter on 4-week EKG Monitor.
- Description
- Primary Endpoints:~The primary outcome is freedom from symptomatic post-procedural AF or flutter at 12 and 15 months from the procedure and less than 1 min/day of AF or flutter on 4-week EKG monitor.
- Time frame
- 15 months
- Population
- total of 343 patients randomized to study which included 158 randomized to standard ablation and 185 to VOM + Standard ablation.
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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