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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 University
  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 July 31, 2014