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 2 family ICD with Rhythm ID or a Medtronic ICD using the Enhanced PR Logic or Wavelet 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.
RCT Entities:
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 2 family ICD with Rhythm ID or a Medtronic ICD using the Enhanced PR Logic or Wavelet 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.