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Comparison · NCT00911508-8cbb5853

Left Atrial Ablation vs Rate or Rhythm Control Therapy: Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF.

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. Left Atrial Ablation vs Rate or Rhythm Control Therapy: Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF. Trial comparisons, record NCT00911508-8cbb5853. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00911508-8cbb5853

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.08030.06570.0978wilson
Risk in group 20.09220.07640.111wilson
Risk difference, group 1 minus group 2-0.0118-0.03550.0117newcombe hybrid score
Risk ratio, group 1 over group 20.8720.6641.14log
Odds ratio, group 1 over group 20.860.6391.16log
Number needed to treat, for one fewer participant with the outcome on Left Atrial Ablation than on Rate or Rhythm Control Therapy84.5from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Left 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.
891,108OG000
Group 2Rate or Rhythm Control TherapyAll 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.1011,096OG001

Outcome

Type
PRIMARY
Title
Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF.
Description
All events for each component of the primary endpoint were reviewed and adjudicated in a blinded fashion by an independent clinical events committee using prospectively determined event definitions. Death was defined as all-cause mortality, disabling stroke (including intracranial bleeding) as an irreversible physical limitation defined by a Rankin Stroke Scale ≥2, and serious bleeding as bleeding accompanied by hemodynamic compromise that required surgical intervention or a transfusion of ≥3 units of blood.
Time frame
From date of enrollment until time-to-first event over a median follow-up of 48.5 months.
Population

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

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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