Expired Study
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Charleston, South Carolina 29425


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00148954


Primary Contact:

Principal Investigator
Michael Gold, MD, PhD
Medical University of South Carolina


Backup Contact:

N/A


Location Contact:

Charleston, South Carolina 29425
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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