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Trial · NCT00148954

RIGHT: Rhythm ID Going Head-to-Head Trial

NCT00148954, Phase 4, Completed, Boston Scientific Corporation; results first posted 2011-12-26

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. RIGHT: Rhythm ID Going Head-to-Head Trial. Trials, record NCT00148954. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00148954

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
RIGHT: Rhythm ID Going Head-to-Head Trial
NCT number
NCT00148954
Status
Completed
Phases
Phase 4
Enrollment
1,962 participants, actual
Lead sponsor
Boston Scientific Corporation
Conditions
Tachycardia
Interventions
VITALITY 2 Implantable Cardioverter Defibrillator, Medtronic Implantable Cardioverter Defibrillator
First posted
2005-09-08
Last updated
2012-01-12
Results first posted
2011-12-26

Source ClinicalTrials.gov

Registered outcomes4

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

ListOutcomeTime frameDescription
PrimaryNumber of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge VisitFrom date of pre-discharge until a minimum of 12 months follow-up until study closure
An inappropriate therapy is defined as a VT/VF therapy, either shock or antitachycardia pacing (ATP), delivered for a supraventricular tachycardia (SVT). All events for which a VT/VF therapy was delivered and a stored electrogram exists were reviewed by an independent adjudication committee to determine the appropriateness of device rhythm classification and subsequent therapy delivery.
SecondaryTime to First Inappropriate Shock Using VITALITY and Selected Medtronic Implantable Cardioverter Defibrillator (ICDs)Time of event
SecondaryPositive Predictive Value (PPV) of Ventricular Tachycardia/Fibrillation (VT/VF) Discrimination Algorithms Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillators (ICDs)Time of event
SecondaryTime to First Inappropriate Therapy for Which the Discrimination Algorithm Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillator (ICDs) Inappropriately Classified the EpisodeTime of event

Outcomes4

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge VisitFrom date of pre-discharge until a minimum of 12 months follow-up until study closureParticipantsNUMBER
SECONDARYTime to First Inappropriate Shock Using VITALITY and Selected Medtronic Implantable Cardioverter Defibrillator (ICDs)Time of event
SECONDARYPositive Predictive Value (PPV) of Ventricular Tachycardia/Fibrillation (VT/VF) Discrimination Algorithms Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillators (ICDs)Time of event
SECONDARYTime to First Inappropriate Therapy for Which the Discrimination Algorithm Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillator (ICDs) Inappropriately Classified the EpisodeTime of event

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge VisitVITALITY 2246Participants
Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge VisitMedtronic Family187Participants

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDVITALITY 2985
Overall StudySTARTEDMedtronic Family977
Overall StudyCOMPLETEDVITALITY 2678
Overall StudyCOMPLETEDMedtronic Family677
Overall StudyNOT COMPLETEDVITALITY 2307
Overall StudyNOT COMPLETEDMedtronic Family300

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherPulse generator RelatedCardiac disordersVITALITY 23398533
otherPulse generator RelatedCardiac disordersMedtronic Family2197721
otherRight atrial lead relatedCardiac disordersVITALITY 21898525
otherRight atrial lead relatedCardiac disordersMedtronic Family1197711
otherRight ventricular lead relatedCardiac disordersVITALITY 24898557
otherRight ventricular lead relatedCardiac disordersMedtronic Family6097777
otherProcedure relatedCardiac disordersVITALITY 23098532
otherProcedure relatedCardiac disordersMedtronic Family2597726
otherCardiovascular relatedCardiac disordersVITALITY 2410985769
otherCardiovascular relatedCardiac disordersMedtronic Family373977690

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityVITALITY 2
Total, all-cause mortalityMedtronic Family
Total, other adverse eventsVITALITY 2535985
Total, other adverse eventsMedtronic Family508977
Total, serious adverse eventsVITALITY 200
Total, serious adverse eventsMedtronic Family00

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
16836672RESULTPubMed
21978966DERIVEDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
VITALITY 2 vs Medtronic Family: Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00148954

GET https://conductscience.org/api/trials/v1/NCT00148954/registered