RIGHT: Rhythm ID Going Head-to-Head Trial

NCT00148954 | Completed Phase 4 Results DMC

• 2 other identifiers: CR-CA-032105-TRIGHT
• Study Type: interventional
• Target: 1,962
• Locations: 1 country
• Sites: 1

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.

Conditions

Tachycardia

Outcome Measures

Primary Outcomes (1)

• 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.

  From date of pre-discharge until a minimum of 12 months follow-up until study closure

Secondary Outcomes (3)

• Time to First Inappropriate Shock Using VITALITY and Selected Medtronic Implantable Cardioverter Defibrillator (ICDs)

  Time of event

• Positive Predictive Value (PPV) of Ventricular Tachycardia/Fibrillation (VT/VF) Discrimination Algorithms Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillators (ICDs)

  Time of event

• 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 of event

Study Arms (2)

Implantable Cardioverter Defibrillator - Boston Scientific

ACTIVE COMPARATOR

VITALITY 2 ICD

Device: VITALITY 2 Implantable Cardioverter Defibrillator

Implantable Cardioverter Defibrillator - Medtronic

ACTIVE COMPARATOR

Selected Medtronic family ICD

Device: Medtronic Implantable Cardioverter Defibrillator

Interventions

VITALITY 2 Implantable Cardioverter Defibrillator DEVICE

VITALITY 2 ICD

Implantable Cardioverter Defibrillator - Boston Scientific

Medtronic Implantable Cardioverter Defibrillator DEVICE

Maximo, Marquis, Intrinsic, Virtuoso, or Entrust ICD

Implantable Cardioverter Defibrillator - Medtronic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (2)

• 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.

  PMID: 16836672 RESULT

• 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.

  PMID: 21978966 DERIVED

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Greg Voss, Clinical Director
• Organization: Boston Scientific

gregory.voss@bsci.com

651-581-3068

Study Officials

• Michael Gold, MD, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Ron Berger, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: July 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: July 1, 2010
• Last Updated: January 12, 2012
• Results First Posted: December 26, 2011

Record last verified: 2012-01

Locations

US (1)