NCT00148954

RIGHT: Rhythm ID Going Head-to-Head Trial

Rhythm ID Going Head-to-head Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,962 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tachycardia

Interventions

Type	Name	Description
DEVICE	VITALITY 2 Implantable Cardioverter Defibrillator	VITALITY 2 ICD
DEVICE	Medtronic Implantable Cardioverter Defibrillator	Maximo, Marquis, Intrinsic, Virtuoso, or Entrust ICD

Timeline

• Start date: 2005-07-01
• Primary completion: 2009-03-01
• Completion: 2010-07-01
• First posted: 2005-09-08
• Last updated: 2012-01-12
• Results posted: 2011-12-26

Locations

1 site across 1 country: United States