Status:
COMPLETED
RIGHT: Rhythm ID Going Head-to-Head Trial
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Tachycardia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ICD...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
1962 Patients enrolled
Trial Details
Trial ID
NCT00148954
Start Date
July 1 2005
End Date
July 1 2010
Last Update
January 12 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425