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Trial · NCT01215253

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Patients With Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF) or Death2 years of follow-up on average
Primary endpoint of the study will be defined as a composite endpoint consisting of Ventricular Tachycardia or Ventricular Fibrillation requiring antitachycardia pacing (ATP) therapy, implantable cardioverter-defibrillator (ICD) shock, or death, whichever occurs first.
SecondaryNumber of Patients With VT or VF Requiring ICD Shock or Death2 years of follow-up on averageImplantable cardioverter-defibrillator (ICD) shock for VT or VF or death, whichever occurs first.
SecondaryNumber of Recurrent Episodes of VT or VF Requiring Antitachycardia Pacing (ATP) or ICD Shock Therapies2 years of follow-up on averageTotal number of recurrent ICD therapies requiring antitachycardia pacing (ATP) or shock will be analyzed, not just first event
SecondaryNumber of Patients With First Inappropriate ICD Shock2 years of follow-up on averageNumber of patients with first inappropriate ICD shock for other reasons than VT or VF
SecondaryNumber of Patients With Hospitalization for Cardiac Causes or Death, Whichever Occurred First.2 years of follow-up on averageNumber of patients with a composite endpoint of cardiovascular hospitalization or death, whichever occurred first.
SecondaryNumber of Patients With Heart Failure Hospitalization or Death, Whichever Occurred First2 years of follow-up on averageNumber of patients with a composite endpoint of heart failure hospitalization or death, whichever occurred first.
SecondaryDeath2 years of follow-up on averageDeath as a safety endpoint of the trial
SecondaryMean Meters Walked in 6 Minutes1 year of follow-upExercise capacity measured by the 6-minute walk test
SecondaryQuality of Life Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)1 year follow-up
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a new, self-administered, 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. The scale ranges from 0-100 with lower scores indicating worse outcomes.
SecondaryNumber of Recurrent Inappropriate ICD Shocks2 years of follow-up on averageNumber of recurrent inappropriate ICD shocks in all patients combined.
OtherNumber of Patients Whose First VT/VF Required Antitachycardia Pacing (ATP)2 years of follow-up on averageNumber of patients whose first VT or VF required antitachycardia pacing (ATP)
OtherNumber of Patients Whose First VT/VF Required ICD Shock2 years of follow-up on averagenumber of patients whose first VT or VF required ICD shock

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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