RIGHT: Rhythm ID Going Head-to-Head Trial

Boston Scientific

Status and phase: Completed; Phase 4

Conditions: Tachycardia

Treatments: Device: Medtronic Implantable Cardioverter Defibrillator; Device: VITALITY 2 Implantable Cardioverter Defibrillator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00148954

RIGHT

CR-CA-032105-T

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,962 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,962 participants in 2 patient groups

Implantable Cardioverter Defibrillator - Boston Scientific

Active Comparator group

Description:

VITALITY 2 ICD

Treatment:

Device: VITALITY 2 Implantable Cardioverter Defibrillator

Implantable Cardioverter Defibrillator - Medtronic

Active Comparator group

Description:

Selected Medtronic family ICD

Treatment:

Device: Medtronic Implantable Cardioverter Defibrillator