Comparison · NCT00911508-sae
Left Atrial Ablation vs Rate or Rhythm Control Therapy: 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. Left Atrial Ablation vs Rate or Rhythm Control Therapy: serious adverse events. Trial comparisons, record NCT00911508-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00911508-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 | 0.41 | 0.381 | 0.439 | wilson | |
| Risk in group 2 | 0.392 | 0.364 | 0.422 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0174 | -0.0235 | 0.0582 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.943 | 1.16 | log | |
| Odds ratio, group 1 over group 2 | 1.08 | 0.907 | 1.27 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Left Atrial Ablation than on Rate or Rhythm Control Therapy | 57.4 | 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 | Left Atrial Ablation | All patients randomized to the ablation group were required to undergo left atrial pulmonary vein isolation. The addition of ancillary ablation techniques including linear, ganglion plexus, and electrogram-based approaches were left to the discretion of the investigators. | 454 | 1,108 | EG000 |
| Group 2 | Rate or Rhythm Control Therapy | All patients randomized to drug therapy, were treated with standard rhythm and/or rate control drugs selected in accordance with contemporary guidelines, according to investigator discretion. | 430 | 1,096 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected from time of enrollment through study completion over a median follow-up duration of 48.5 months.
Source ClinicalTrials.gov
Trial
- Title
- Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
- NCT number
- NCT00911508
- Phases
- NA
- Conditions
- Atrial Fibrillation, Arrhythmia
- Interventions
- Left atrial ablation, Rate or Rhythm Control Therapy
- Lead sponsor
- Mayo Clinic
- Results first posted
- 2019-08-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00911508?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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