RIGHT: Rhythm ID Going Head-to-Head Trial

Boston Scientific Corporation1,962 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,962

Conditions

Tachycardia

Interventions

VITALITY 2 Implantable Cardioverter DefibrillatorDEVICE

VITALITY 2 ICD

Medtronic Implantable Cardioverter DefibrillatorDEVICE

Maximo, Marquis, Intrinsic, Virtuoso, or Entrust ICD

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

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

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.

Time frame: From date of pre-discharge until a minimum of 12 months follow-up until study closure

Secondary Outcomes

Time to First Inappropriate Shock Using VITALITY and Selected Medtronic Implantable Cardioverter Defibrillator (ICDs)

Time frame: 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 frame: 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 frame: Time of event

Data from ClinicalTrials.gov

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