RIGHT: Rhythm ID Going Head-to-Head Trial

Phase 4

Completed

Interventions: Device: VITALITY 2 Implantable Cardioverter Defibrillator
Device: Medtronic Implantable Cardioverter Defibrillator

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Implantable Cardioverter Defibrillator - Boston Scientific	VITALITY 2 Implantable Cardioverter Defibrillator	VITALITY 2 ICD
Implantable Cardioverter Defibrillator - Medtronic	Medtronic Implantable Cardioverter Defibrillator	Selected Medtronic family ICD

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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