At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 1,962 enrolled
Drug / intervention
VITALITY 2 Implantable Cardioverter Defibrillator +1 moredevice
Likely dose
Not stated in record
Key inclusion· 4
- ✓Meet current indications for an ICD
- ✓Sign informed consent form before implant
- ✓Remain in clinical care of enrolling physician at approved centers
- ✓Able to tolerate ICD programming as prescribed in protocol
Key exclusion· 7
- ✕Third-degree heart block
- ✕Life expectancy less than 12 months
- ✕Other cardiac surgeries or procedures planned during study duration
- ✕Currently enrolled in another investigational study or registry that would impact treatment or outcome
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Rhythm ID Going Head-to-head Trial
In Brief
A Phase 4 clinical trial evaluating VITALITY 2 Implantable Cardioverter Defibrillator and Medtronic Implantable Cardioverter Defibrillator for Tachycardia. Completed, enrolled 1,962 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTachycardia
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2005
First PostedSep 2005
Primary CompletionMar 2009
Study CompletionJul 2010
TodayJul 2026
First PostedSep 8, 2005
Enrollment StartJul 1, 2005
Primary CompletionMar 1, 2009
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 20.8 years ago
Interventions
VITALITY 2 Implantable Cardioverter Defibrillatordevice
VITALITY 2 ICD
Medtronic Implantable Cardioverter Defibrillatordevice
Maximo, Marquis, Intrinsic, Virtuoso, or Entrust ICD