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RIGHT: Rhythm ID Going Head-to-Head Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00148954
First received: September 6, 2005
Last updated: January 10, 2012
Last verified: January 2012
History of Changes
  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.


Condition Intervention Phase
Tachycardia
 Device: VITALITY 2 Implantable Cardioverter Defibrillator
Device: Medtronic Implantable Cardioverter Defibrillator
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Rhythm ID Going Head-to-head Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

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 [ Time Frame: From date of pre-discharge until a minimum of 12 months follow-up until study closure ] [ Designated as safety issue: No ]
    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) [ Time Frame: Time of event ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 1962
Study Start Date: July 2005
Study Completion Date: July 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Implantable Cardioverter Defibrillator - Boston Scientific
VITALITY 2 ICD
 Device: VITALITY 2 Implantable Cardioverter Defibrillator
VITALITY 2 ICD
Active Comparator: Implantable Cardioverter Defibrillator - Medtronic
Selected Medtronic family ICD
 Device: Medtronic Implantable Cardioverter Defibrillator
Maximo, Marquis, Intrinsic, Virtuoso, or Entrust 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148954

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Michael Gold, MD, PhD Medical University of South Carolina
Principal Investigator: Ron Berger, MD, PhD Johns Hopkins Medical Institutions
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00148954     History of Changes
Other Study ID Numbers: CR-CA-032105-T, RIGHT
Study First Received: September 6, 2005
Results First Received: October 7, 2011
Last Updated: January 10, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013