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Trial · NCT05511246

Registered outcomes21

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

ListOutcomeTime frameDescription
PrimaryVentricular tachycardia recurrence0-12 monthsDetection of VT on defibrillator
PrimaryHospitalization for cardiac causes0-12 months
PrimarySevere procedural complications0-12 months
Severe procedural complications include bleeding requiring transfusion, stroke or systemic embolization, pericardial tamponade, myocardial infarction, and vascular complications requiring surgery, plus cardiogenic shock requiring unplanned mechanical support.
PrimaryDeath0-12 months
SecondaryProcedural timeDuring procedureTotal procedure time (minutes)
SecondaryNeed for unplanned mechanical hemodynamic supportDuring procedureUnplanned use of intra-aortic balloon pump or ventricular assist device during procedure (Yes/No)
SecondaryRepeat ablation procedures, including epicardial0-12 monthsNeed for repeat procedure (Yes/No)
SecondaryAll-cause mortality0-12 months
SecondaryAppropriate ICD therapies: antitachycardia pacing and ICD shocks0-12 monthsPresence of appropriate ICD therapies on interrogation
SecondaryInappropriate ICD therapies: antitachycardia pacing and ICD shocks0-12 monthsPresence of inappropriate ICD therapies on interrogation
SecondaryChange in ICD therapies compared to 3-months pre-randomization0-12 monthsComparison of number of therapies on ICD interrogation
SecondaryVt storm0-12 monthsMore than 2 episodes of VT within a 24h period
SecondarySustained VT below detection rate0-12 months
SecondaryChange in left ventricular ejection fraction (percent)Before and 3 months post-procedureMeasured before and 3 months after procedure
SecondaryQuality of life measurement using SF-32 questionnaire0-12 monthsScores range from 0 - 100; Lower scores = more disability, higher scores = less disability
SecondaryHospital admission for cardiac causes (including heart failure exacerbation)0-12 monthsHospitalization due to cardiac arrhythmia, heart failure exacerbation and other cardiac causes (yes/no)
SecondaryAntiarrhtyhmic therapy0-12 monthsNumber of antiarrhythmic drugs before and after ablation
SecondaryFreedom from VT after repeat procedures0-12 monthsRecurrence of VT (yes/no) including patients that have multiple ablations
SecondaryCardiac transplant or left ventricular assist device implantation0-12 monthsAs a measure of deterioration of cardiac status, requirement of transplant of ventricular assist device implant (yes/no) will be compared
SecondaryFluoroscopy timeDuring procedureTotal time of fluoroscopy use (minutes)

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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