RIGHT: Rhythm ID Going Head-to-Head Trial

Tachycardia Clinical Trial

Official title:

Rhythm ID Going Head-to-head Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148954
• Other study ID #: CR-CA-032105-T
• Secondary ID: RIGHT
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2005
• Last updated: January 10, 2012
• Start date: July 2005
• Est. completion date: July 2010

Study information

• Verified date: January 2012
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1962
• Est. completion date: July 2010
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tachycardia

Intervention

Device:
• VITALITY 2 Implantable Cardioverter Defibrillator
VITALITY 2 ICD
• Medtronic Implantable Cardioverter Defibrillator
Maximo, Marquis, Intrinsic, Virtuoso, or Entrust ICD

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time to First Inappropriate Shock Using VITALITY and Selected Medtronic Implantable Cardioverter Defibrillator (ICDs)		Time of event	No
Secondary	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	No
Secondary	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	No