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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
Results First Received: October 7, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Tachycardia
Interventions: Device: VITALITY 2 Implantable Cardioverter Defibrillator
Device: Medtronic Implantable Cardioverter Defibrillator

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
VITALITY 2 VITALITY 2 ICD
Medtronic Family Selected Medtronic family devices

Participant Flow:   Overall Study
    VITALITY 2   Medtronic Family
STARTED   985   977 
COMPLETED   678   677 
NOT COMPLETED   307   300 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
VITALITY 2 VITALITY 2 ICD
Medtronic Family Selected Medtronic family devices
Total Total of all reporting groups

Baseline Measures
   VITALITY 2   Medtronic Family   Total 
Overall Participants Analyzed 
[Units: Participants]
 985   977   1962 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   489   482   971 
>=65 years   496   495   991 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.3  (12.4)   64.4  (12.0)   64.3  (12.2) 
Gender 
[Units: Participants]
     
Female   223   197   420 
Male   762   780   1542 
Region of Enrollment 
[Units: Participants]
     
United States   915   909   1824 
Europe   65   63   128 
Canada   5   5   10 


  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Time to First Inappropriate Shock Using VITALITY and Selected Medtronic Implantable Cardioverter Defibrillator (ICDs)   [ Time Frame: Time of event ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  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 Frame: Time of event ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Greg Voss, Clinical Director
Organization: Boston Scientific
phone: 651-581-3068
e-mail: gregory.voss@bsci.com


Publications of Results:
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