The Rhythm ID Going Head to Head Trial (RIGHT): design of a randomized trial comparing competitive rhythm discrimination algorithms in implantable cardioverter defibrillators.
Background: The implantable cardioverter defibrillator (ICD) has become primary therapy for the prevention of sudden death. One of the major morbidities of ICD use remains inappropriate therapy for supraventricular arrhythmias (SVA). Detection enhancements have increased therapy specificity, but the...
| Published in: | Journal of Cardiovascular Electrophysiology Vol. 17; no. 7; pp. 749 - 754 |
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| Main Authors: | , , , , |
| Format: | research tables/charts Journal Article |
| Published: |
Wiley-Blackwell
Jul2006
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=106169108&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 106169108 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 10453873 GSB jtl: Journal of Cardiovascular Electrophysiology issn: 10453873 maglogo: Y pubinfo: dt: Jul2006 vid: 17 iid: 7 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 106169108 2009259618 10.1111/j.1540-8167.2006.00463.x NLM16836672 106169108 ppf: 749 ppct: 5 formats: fmt: @attributes: type: P tig: atl: The Rhythm ID Going Head to Head Trial (RIGHT): design of a randomized trial comparing competitive rhythm discrimination algorithms in implantable cardioverter defibrillators. aug: au: Berger RD Lerew DR Smith JM Pulling C Gold MR affil: Johns Hopkins Medical Institutions, Baltimore, Maryland sug: subj: Arrhythmia Defibrillators, Implantable Diagnosis, Differential Funding Source Study Design Human ab: Background: The implantable cardioverter defibrillator (ICD) has become primary therapy for the prevention of sudden death. One of the major morbidities of ICD use remains inappropriate therapy for supraventricular arrhythmias (SVA). Detection enhancements have increased therapy specificity, but their impact on inappropriate therapy is not well studied. Moreover, ICD manufacturers have developed unique algorithms to meet this goal, with no previous clinical direct comparisons. RIGHT is a randomized, prospective study that will assess the differential efficacy of ICDs from two different manufacturers. It is the first trial to compare directly competitive ICD rhythm discrimination algorithms on a large scale. Objective: The primary objective of this study is to assess arrhythmia discrimination in Guidant versus Medtronic ICDs by comparing the time to first inappropriate therapy after the predischarge visit. Methods: The study will enroll approximately 2,000 patients in 100 centers. Patients will be randomized to Guidant or Medtronic using a permuted block design, stratified by center and by single/dual chamber device types. Patients will receive a commercially available Guidant VITALITY(R) 2 family ICD with Rhythm ID[TM] or a Medtronic ICD using the Enhanced PR Logic[TM] or Wavelet[TM] discrimination algorithms, and will be followed according to the schedule shown until a common closing date with a minimum follow-up of 12 months. All events will be reviewed by an independent committee to determine the appropriateness of rhythm classification and therapy delivery. Conclusion: RIGHT is the first randomized, large scale, head-to-head comparison of ICD discrimination algorithms. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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