RIGHT is a randomized, prospective, two-arm study that will assess the differential efficacy of Guidant ICDs using Rhythm ID™ versus protocol specified commercially available competitive ICDs.

Condition	Intervention	Phase
Tachycardia	Device: Implantable Cardioverter Defibrillator	Phase IV

Further Study Details: 

Primary Outcomes: Time to first inappropriate VT/VF therapy (shock or ATP)after the Pre-Discharge visit.

RIGHT will compare the incidence of VT/VF therapies delivered for SVT episodes using Guidant 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00148954

Michael Gold, MD, PhD       goldmr@musc.edu
Ron Berger, MD, PhD       rberger@jhmi.edu

South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States; Recruiting

Study chairs or principal investigators

Michael Gold, MD, PhD,  Principal Investigator,  Medical University of South Carolina   
Ron Berger, MD, PhD,  Principal Investigator,  Johns Hopkins Medical Institutions   

Study ID Numbers:  CR-CA-032105-T
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00148954
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13