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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit | From 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. |
| Secondary | Time to First Inappropriate Shock Using VITALITY and Selected Medtronic Implantable Cardioverter Defibrillator (ICDs) | Time of event | |
| Secondary | Positive Predictive Value (PPV) of Ventricular Tachycardia/Fibrillation (VT/VF) Discrimination Algorithms Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillators (ICDs) | Time of event | |
| Secondary | Time to First Inappropriate Therapy for Which the Discrimination Algorithm Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillator (ICDs) Inappropriately Classified the Episode | Time of event |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit | From date of pre-discharge until a minimum of 12 months follow-up until study closure | Participants | NUMBER | |
| SECONDARY | Time to First Inappropriate Shock Using VITALITY and Selected Medtronic Implantable Cardioverter Defibrillator (ICDs) | Time of event | |||
| SECONDARY | Positive Predictive Value (PPV) of Ventricular Tachycardia/Fibrillation (VT/VF) Discrimination Algorithms Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillators (ICDs) | Time of event | |||
| SECONDARY | Time to First Inappropriate Therapy for Which the Discrimination Algorithm Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillator (ICDs) Inappropriately Classified the Episode | Time of event |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit | VITALITY 2 | 246 | Participants | ||
| Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit | Medtronic Family | 187 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | VITALITY 2 | 985 | |
| Overall Study | STARTED | Medtronic Family | 977 | |
| Overall Study | COMPLETED | VITALITY 2 | 678 | |
| Overall Study | COMPLETED | Medtronic Family | 677 | |
| Overall Study | NOT COMPLETED | VITALITY 2 | 307 | |
| Overall Study | NOT COMPLETED | Medtronic Family | 300 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pulse generator Related | Cardiac disorders | VITALITY 2 | 33 | 985 | 33 |
| other | Pulse generator Related | Cardiac disorders | Medtronic Family | 21 | 977 | 21 |
| other | Right atrial lead related | Cardiac disorders | VITALITY 2 | 18 | 985 | 25 |
| other | Right atrial lead related | Cardiac disorders | Medtronic Family | 11 | 977 | 11 |
| other | Right ventricular lead related | Cardiac disorders | VITALITY 2 | 48 | 985 | 57 |
| other | Right ventricular lead related | Cardiac disorders | Medtronic Family | 60 | 977 | 77 |
| other | Procedure related | Cardiac disorders | VITALITY 2 | 30 | 985 | 32 |
| other | Procedure related | Cardiac disorders | Medtronic Family | 25 | 977 | 26 |
| other | Cardiovascular related | Cardiac disorders | VITALITY 2 | 410 | 985 | 769 |
| other | Cardiovascular related | Cardiac disorders | Medtronic Family | 373 | 977 | 690 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | VITALITY 2 | ||
| Total, all-cause mortality | Medtronic Family | ||
| Total, other adverse events | VITALITY 2 | 535 | 985 |
| Total, other adverse events | Medtronic Family | 508 | 977 |
| Total, serious adverse events | VITALITY 2 | 0 | 0 |
| Total, serious adverse events | Medtronic Family | 0 | 0 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 |
Source Trial comparisons
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.
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