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TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD (Centurion)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TYRX, Inc.
ClinicalTrials.gov Identifier:
NCT01043705
First received: January 5, 2010
Last updated: November 20, 2015
Last verified: October 2015
Results First Received: October 13, 2015  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Condition: Cardiac Implantable Electronic Device Infection

  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
First Patient Enrolled = 1 January 2010; Last Patient Enrolled = 7 May 2013

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
CRT and ICD Implant patients with TYRX Implant; Full analysis cohort = 1,129 patients. 670 patient CRT + TYRX cohort is subset. 459 patient ICD + TYRX is subset. 578 CRT+ TYRX patient cohort is subset matched to 578 patient CRT/no TYRX retrospective patient arm.

Reporting Groups
  Description
ICD With TYRX Implant All patients receiving a TYRX envelope who were eligible to participate having a replacement ICD implant
CRT and TYRX Cases, Matched to Retrospective Non-TYRX Implants Patients receiving a TYRX envelope who were eligible to participate having a replacement CRT implant who have a valid non-TYRX implant case-match
CRT With no TYRX Retrospective Case Control Retrospective site matched and case-matched CRT replacement patients who did not receive a TYRX envelope selected in the era just prior to availability of TYRX Envelope

Participant Flow:   Overall Study
    ICD With TYRX Implant     CRT and TYRX Cases, Matched to Retrospective Non-TYRX Implants     CRT With no TYRX Retrospective Case Control  
STARTED     459     578     578  
COMPLETED     352     447     498  
NOT COMPLETED     107     131     80  
Death                 28                 60                 26  
Lost to Follow-up                 27                 12                 0  
Multiple Reasons                 4                 7                 0  
Protocol Violation                 2                 1                 0  
Withdrawal by Subject                 8                 6                 0  
Site Closure                 8                 0                 0  
Subsequent Procedure                 9                 24                 29  
Adverse Event                 0                 2                 0  
Screen Fail                 21                 0                 0  
Unspecified                 0                 19                 25  



  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.
Prospective Population: ICD and CRT replacement implant patients receiving a TYRX Envelope Retrospective Population: CRT Patients receiving a CRT and no TYRX envelope. Patients are site medical charts from just previous to use of TYRX Evelope

Reporting Groups
  Description
CIED Replacement With ICD and TYRX (Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.
CIED Replacement With CRT and no TYRX (Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.
CIED Replacement With CRT and TYRX Vs. Case Match Arm Prospective CRT patients who received a TYRX envelope and had a valid case match retrospective patient. This is a subset of all CRT/TYRX patients
Total Total of all reporting groups

Baseline Measures
    CIED Replacement With ICD and TYRX     CIED Replacement With CRT and no TYRX     CIED Replacement With CRT and TYRX Vs. Case Match Arm     Total  
Number of Participants  
[units: participants]
  459     578     578     1615  
Age  
[units: Years]
Median (Standard Deviation)
  70  (12.01)     73  (10.94)     73  (10.70)     72  (11.45)  
Gender  
[units: participants]
       
Female     339     434     444     1217  
Male     120     144     134     398  



  Outcome Measures
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1.  Primary:   Major CIED Infection   [ Time Frame: 12 months ]

2.  Primary:   CIED Mechanical Complication   [ Time Frame: 12 months ]


  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
This was a non-randomized study and did not have an active comparator.


  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: Lynn Landborg, Clinical Research Manager
Organization: Medtronic plc
phone: 763 526 2877
e-mail: lynn.landborg@medtronic.com


Publications:

Responsible Party: TYRX, Inc.
ClinicalTrials.gov Identifier: NCT01043705     History of Changes
Obsolete Identifiers: NCT01043861
Other Study ID Numbers: CP-2009-2
Study First Received: January 5, 2010
Results First Received: October 13, 2015
Last Updated: November 20, 2015
Health Authority: United States: Institutional Review Board