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Trial · NCT00911508

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF.From date of enrollment until time-to-first event over a median follow-up of 48.5 months.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With All-cause MortalityFrom date of enrollment until date of death over a median follow-up of 48.5 months.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Mortality or Cardiovascular (CV) HospitalizationFrom date of enrollment until time-to-first event of death or CV hospitalization over a median follow-up of 48.5 months.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Mortality, Disabling Stroke, or CV Hospitalization (for Heart Failure or Acute Ischemic Events)From date of enrollment until time-to-first event of death, stroke, or CV hospitalization (for heart failure or acute ischemic event) over a median follow-up of 48.5 months.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Cardiovascular DeathFrom date of enrollment until date of a cardiovascular death over a median follow-up of 48.5 months.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Cardiovascular Death or Disabling StrokeFrom date of enrollment until time-to-first event of a cardiovascular death or disabling stroke over a median follow-up of 48.5 months.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With an Arrhythmic Death or Cardiac ArrestFrom date of enrollment until time-to-first event for an arrhythmic death or cardiac arrest over a median follow-up of 48.5 months.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Heart Failure DeathFrom date of enrollment until date of heart failure death over a median follow-up of 48.5 months.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Free From Recurrent Atrial Fibrillation (AF) Following the 90 Day Blanking PeriodFrom date of therapy initiation until date of first AF recurrence following a 90 day wait (blanking) period over a median follow-up of 48.5 months.Subjects were analyzed in the post-blanking period if randomized treatment occurred and the subject did not die, withdraw, or get lost to follow-up before the end of the 90 day blanking period.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Cardiovascular HospitalizationFrom date of enrollment until date of cardiovascular hospitalization over a median follow-up of 48.5 months.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYChanges in Quality of Life Measures - AFEQTBaseline ,12 month, 5 yearsOnly patients with questionnaire data were analyzed.units on a scaleMEAN
SECONDARYChanges in Quality of Life Measures - MAFSI Frequency ScoreBaseline, 12 Month, 5 YearOnly patients with questionnaire data were analyzed.units on a scaleMEAN
SECONDARYChanges in Quality of Life Measures - MAFSI Severity ScoreBaseline, 12 Month, 5 YearOnly patients with questionnaire data were analyzed.units on a scaleMEAN
SECONDARYNumber of Participants With Adverse Events/ComplicationsFrom treatment start date to date of event over a median follow-up of 48.5 months.
Ablation-related events were counted among all patients that were randomized to and received an ablation.~Drug-related events were counted among all patients that were randomized to and received drug therapy.
ParticipantsCOUNT_OF_PARTICIPANTS

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
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
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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