Rhythm ID Going Head-to-head Trial
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Tachycardia
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 1962
- Locations
- 1
- Primary Endpoint
- Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief 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.
Detailed Description
RIGHT will compare the incidence of Ventricular Tachycardia/Fibrillation (VT/VF) therapies delivered for Supraventricular Tachycardia (SVT) episodes using VITALITY 2 devices with Rhythm ID™ to that of ICDs employing other rhythm discrimination algorithms. Appropriateness of therapies will be assessed after independent adjudication of all VT/VF events leading to therapy. Comparisons will be made between device manufacturers across patient populations receiving either a dual- or single-chamber device.
Investigators
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
Outcomes
Primary Outcomes
Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit
Time Frame: 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 Outcomes
- Time to First Inappropriate Shock Using VITALITY and Selected Medtronic Implantable Cardioverter Defibrillator (ICDs)(Time of event)
- 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)
- 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)