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Comparison · NCT00180271-sae

Cardiac Resynchronization Therapy + Defibrillator vs Implantable Cardioverter Defibrillator Alone: 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. Cardiac Resynchronization Therapy + Defibrillator vs Implantable Cardioverter Defibrillator Alone: serious adverse events. Trial comparisons, record NCT00180271-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00180271-sae

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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 10.1520.1320.175wilson
Risk in group 20.07720.05980.0992wilson
Risk difference, group 1 minus group 20.07470.04490.103newcombe hybrid score
Risk ratio, group 1 over group 21.971.472.63log
Odds ratio, group 1 over group 22.141.552.95log
Number needed to harm, for one more participant with a serious adverse event on Cardiac Resynchronization Therapy + Defibrillator than on Implantable Cardioverter Defibrillator Alone13.49.6822.3from the risk difference interval

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Cardiac Resynchronization Therapy + Defibrillator
Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
1641,079EG000
Group 2Implantable Cardioverter Defibrillator Alone
Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.
55712EG001

Harm

What it counts
Total, serious adverse events
Time frame
91 Days

Source ClinicalTrials.gov

Trial

Title
MADIT-CRT: Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy
NCT number
NCT00180271
Phases
NA
Conditions
Tachycardia, Congestive Heart Failure
Interventions
Cardiac resynchronization therapy with defibrillation, Implantable Cardioverter Defibrillator (ICD)
Lead sponsor
Boston Scientific Corporation
Results first posted
2011-06-02

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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