Phase 4
N=1,962
RIGHT: Rhythm ID Going Head-to-Head Trial
Tachycardia
Bottom Line
View on ClinicalTrials.gov: NCT00148954 ↗Enrolled (actual)
1,962
Serious AEs
—
Results posted
Dec 2011
Primary outcome: Primary: Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit — 246; 187 Participants — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- VITALITY 2 Implantable Cardioverter Defibrillator (Device); Medtronic Implantable Cardioverter Defibrillator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit |
246; 187 | 0.003 sig |
| SECONDARY Time to First Inappropriate Shock Using VITALITY and Selected Medtronic Implantable Cardioverter Defibrillator (ICDs) |
— | — |
| SECONDARY Positive Predictive Value (PPV) of Ventricular Tachycardia/Fibrillation (VT/VF) Discrimination Algorithms Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillators (ICDs) |
— | — |
| 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 |
— | — |
Summary
RIGHT is a randomized, prospective, two-arm study that will assess the differential efficacy of VITALITY 2 implantable cardioverter defibrillators (ICDs) using Rhythm ID™ versus selected Medtronic ICDs.
Eligibility Criteria
Inclusion Criteria
- Patients who meet current indications for an ICD
- Patients who sign and date a Patient Informed Consent form prior to the implant visit
- Patients who remain in the clinical care of the enrolling physician in approved centers
- Patients who are able to tolerate ICD programming as specifically prescribed in the study protocol
Exclusion Criteria
- Patients who are in third degree heart block
- Patients whose life expectancy is less than 12 months
- Patients who have other cardiac surgeries or procedures planned but not yet performed during the duration of the study
- Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study
- Patients who are younger than 18 years of age
- Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study
- Patients who are pregnant or plan to become pregnant during the study
Data sourced from ClinicalTrials.gov (NCT00148954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.