Back to resultsRIGHT: Rhythm ID Going Head-to-Head Trial
Primary Purpose
Tachycardia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
VITALITY 2 Implantable Cardioverter Defibrillator
Medtronic Implantable Cardioverter Defibrillator
Sponsored by
About this trial
This is an interventional prevention trial for Tachycardia
Eligibility 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
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Implantable Cardioverter Defibrillator - Boston Scientific
Implantable Cardioverter Defibrillator - Medtronic
Arm Description
VITALITY 2 ICD
Selected Medtronic family ICD
Outcomes
Primary Outcome Measures
Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit
An inappropriate therapy is defined as a VT/VF therapy, either shock or antitachycardia pacing (ATP), delivered for a supraventricular tachycardia (SVT). All events for which a VT/VF therapy was delivered and a stored electrogram exists were reviewed by an independent adjudication committee to determine the appropriateness of device rhythm classification and subsequent therapy delivery.
Secondary Outcome Measures
Time to First Inappropriate Shock Using VITALITY and Selected Medtronic Implantable Cardioverter Defibrillator (ICDs)
Positive Predictive Value (PPV) of Ventricular Tachycardia/Fibrillation (VT/VF) Discrimination Algorithms Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillators (ICDs)
Time to First Inappropriate Therapy for Which the Discrimination Algorithm Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillator (ICDs) Inappropriately Classified the Episode
Full Information
NCT ID
NCT00148954
First Posted
September 6, 2005
Last Updated
January 10, 2012
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00148954
Brief Title
RIGHT: Rhythm ID Going Head-to-Head Trial
Official Title
Rhythm ID Going Head-to-head Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 ICDs.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachycardia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1962 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Implantable Cardioverter Defibrillator - Boston Scientific
Arm Type
Active Comparator
Arm Description
VITALITY 2 ICD
Arm Title
Implantable Cardioverter Defibrillator - Medtronic
Arm Type
Active Comparator
Arm Description
Selected Medtronic family ICD
Intervention Type
Device
Intervention Name(s)
VITALITY 2 Implantable Cardioverter Defibrillator
Intervention Description
VITALITY 2 ICD
Intervention Type
Device
Intervention Name(s)
Medtronic Implantable Cardioverter Defibrillator
Intervention Description
Maximo, Marquis, Intrinsic, Virtuoso, or Entrust ICD
Primary Outcome Measure Information:
Title
Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit
Description
An inappropriate therapy is defined as a VT/VF therapy, either shock or antitachycardia pacing (ATP), delivered for a supraventricular tachycardia (SVT). All events for which a VT/VF therapy was delivered and a stored electrogram exists were reviewed by an independent adjudication committee to determine the appropriateness of device rhythm classification and subsequent therapy delivery.
Time Frame
From date of pre-discharge until a minimum of 12 months follow-up until study closure
Secondary Outcome Measure Information:
Title
Time to First Inappropriate Shock Using VITALITY and Selected Medtronic Implantable Cardioverter Defibrillator (ICDs)
Time Frame
Time of event
Title
Positive Predictive Value (PPV) of Ventricular Tachycardia/Fibrillation (VT/VF) Discrimination Algorithms Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillators (ICDs)
Time Frame
Time of event
Title
Time to First Inappropriate Therapy for Which the Discrimination Algorithm Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillator (ICDs) Inappropriately Classified the Episode
Time Frame
Time of event
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Gold, MD, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ron Berger, MD, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16836672
Citation
Berger RD, Lerew DR, Smith JM, Pulling C, Gold MR. The Rhythm ID Going Head to Head Trial (RIGHT): design of a randomized trial comparing competitive rhythm discrimination algorithms in implantable cardioverter defibrillators. J Cardiovasc Electrophysiol. 2006 Jul;17(7):749-53. doi: 10.1111/j.1540-8167.2006.00463.x.
Results Reference
result
PubMed Identifier
21978966
Citation
Gold MR, Ahmad S, Browne K, Berg KC, Thackeray L, Berger RD. Prospective comparison of discrimination algorithms to prevent inappropriate ICD therapy: primary results of the Rhythm ID Going Head to Head Trial. Heart Rhythm. 2012 Mar;9(3):370-7. doi: 10.1016/j.hrthm.2011.10.004. Epub 2011 Oct 4.
Results Reference
derived
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RIGHT: Rhythm ID Going Head-to-Head Trial
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