Comparison · NCT00523978-16dca91a
Cryoablation vs Standard Treatment With Drugs Only: Freedom From Major Atrial Fibrillation Events (MAFEs)
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. Cryoablation vs Standard Treatment With Drugs Only: Freedom From Major Atrial Fibrillation Events (MAFEs). Trial comparisons, record NCT00523978-16dca91a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00523978-16dca91a
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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 | 0.969 | 0.93 | 0.987 | wilson | |
| Risk in group 2 | 0.915 | 0.834 | 0.958 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0547 | -0.00373 | 0.137 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.06 | 0.987 | 1.14 | log | |
| Odds ratio, group 1 over group 2 | 2.95 | 0.906 | 9.6 | log | |
| Number needed to treat, for one more participant with the outcome on Cryoablation than on Standard Treatment With Drugs Only | 18.3 | 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 | Cryoablation | Experimental group or subjects that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter | 158 | 163 | OG000 |
| Group 2 | Standard Treatment With Drugs Only | A control group receiving only an Atrial Fibrillation Drug who have not previously failed a AF study drug. | 75 | 82 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Freedom From Major Atrial Fibrillation Events (MAFEs)
- Description
Subjects that did not have or were free of MAFEs. MAFEs were serious adverse events categorized as cardiovascular death, myocardial infarction, stroke, or hospitalization for AF recurrence/ablation, flutter ablation, embolic events, heart failure, hemorrhage or anti-arrhythmic drug treatment.
- Time frame
- 12 Months
- Population
- mITT set included all subjects (82 CS, 163 ES) who were enrolled, randomized, and received treatment.
Source ClinicalTrials.gov
Trial
- Title
- A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation
- NCT number
- NCT00523978
- Phases
- PHASE3
- Conditions
- Paroxysmal Atrial Fibrillation
- Interventions
- Arctic Front® Cryoablation Catheter, Flecainide or Sotalol or Propafenone
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Results first posted
- 2012-08-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00523978?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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