RIGHT: Rhythm ID Going Head-to-Head Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Rhythm ID Going Head-to-head Trial

Conditions
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Tachycardia

Intervention / Treatment
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* Device: VITALITY 2 Implantable Cardioverter Defibrillator
* Device: Medtronic Implantable Cardioverter Defibrillator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Implantable Cardioverter Defibrillator - Boston Scientific<br>VITALITY 2 ICD | Device: VITALITY 2 Implantable Cardioverter Defibrillator<br>* VITALITY 2 ICD<br>|
| Active Comparator: Implantable Cardioverter Defibrillator - Medtronic<br>Selected Medtronic family ICD | Device: Medtronic Implantable Cardioverter Defibrillator<br>* Maximo, Marquis, Intrinsic, Virtuoso, or Entrust ICD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit | 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. | From date of pre-discharge until a minimum of 12 months follow-up until study closure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |