Clinical trial NCT00148954: RIGHT: Rhythm ID Going Head-to-Head Trial
Official title: Rhythm ID Going Head-to-head Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tachycardia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 1962
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit
timeFrame: From date of pre-discharge until a minimum of 12 months follow-up until study closure
Secondary outcomes:
measure: Time to First Inappropriate Shock Using VITALITY and Selected Medtronic Implantable Cardioverter Defibrillator (ICDs)
timeFrame: Time of event
measure: Positive Predictive Value (PPV) of Ventricular Tachycardia/Fibrillation (VT/VF) Discrimination Algorithms Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillators (ICDs)
timeFrame: Time of event
measure: Time to First Inappropriate Therapy for Which the Discrimination Algorithm Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillator (ICDs) Inappropriately Classified the Episode
timeFrame: Time of event
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Michael Gold, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Ron Berger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.