RIGHT: Rhythm ID Going Head-to-Head Trial

NCT ID: NCT00148954

Last Updated: 2012-01-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1962 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2010-07-31

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.

Conditions

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Tachycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Implantable Cardioverter Defibrillator - Boston Scientific

VITALITY 2 ICD

Group Type ACTIVE_COMPARATOR

VITALITY 2 Implantable Cardioverter Defibrillator

Intervention Type DEVICE

VITALITY 2 ICD

Implantable Cardioverter Defibrillator - Medtronic

Selected Medtronic family ICD

Group Type ACTIVE_COMPARATOR

Medtronic Implantable Cardioverter Defibrillator

Intervention Type DEVICE

Maximo, Marquis, Intrinsic, Virtuoso, or Entrust ICD

Interventions

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VITALITY 2 Implantable Cardioverter Defibrillator

VITALITY 2 ICD

Intervention Type DEVICE

Medtronic Implantable Cardioverter Defibrillator

Maximo, Marquis, Intrinsic, Virtuoso, or Entrust ICD

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Gold, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Ron Berger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

References

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Berger RD, Lerew DR, Smith JM, Pulling C, Gold MR. The Rhythm ID Going Head to Head Trial (RIGHT): design of a randomized trial comparing competitive rhythm discrimination algorithms in implantable cardioverter defibrillators. J Cardiovasc Electrophysiol. 2006 Jul;17(7):749-53. doi: 10.1111/j.1540-8167.2006.00463.x.

Reference Type RESULT
PMID: 16836672 (View on PubMed)

Gold MR, Ahmad S, Browne K, Berg KC, Thackeray L, Berger RD. Prospective comparison of discrimination algorithms to prevent inappropriate ICD therapy: primary results of the Rhythm ID Going Head to Head Trial. Heart Rhythm. 2012 Mar;9(3):370-7. doi: 10.1016/j.hrthm.2011.10.004. Epub 2011 Oct 4.

Reference Type DERIVED
PMID: 21978966 (View on PubMed)

Other Identifiers

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RIGHT

Identifier Type: -

Identifier Source: secondary_id

CR-CA-032105-T

Identifier Type: -

Identifier Source: org_study_id

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