Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT01043705
Eligibility Criteria:
Inclusion Criteria: - Prospective Arms
* Qualifying CIED Implant procedure was replacement with an ICD or CRT and TYRX, with or without lead revision/addition
* Received a complete TYRX Anti-Bacterial Envelope Model# 3122 or #3133 according to the Instructions for Use (IFU)
* Clinically stable to tolerate procedure
* 18 years or older
* Able to return for follow-up care through the 12-month visit, or able to have referring physician provide follow-up data to study site by telephone
Exclusion Criteria: - Prospective Arm
* Unable/unwilling to provide informed consent
* Contraindication to receiving the TYRX device, in accordance with the package labeling
* Pregnant or was at risk for becoming pregnant in the 30 day period following the Qualifying TYRX Implant
* Current CIED infection, or the indication for Qualifying CIED Implant was replacement of CIED that was explanted for infection
* Clinical diagnosis of an active infection at the time of CIED implant, including pneumonia, urinary tract infection, endovascular, cellulitis, bacteremia, or other major systemic infection. (Note: asymptomatic bacteremia without UTI is not an exclusion criterion)
* Generator replacement required planned lead extraction
* Participating in another clinical study evaluating a drug or device designed to reduce CIED infections
* Life expectancy of less than 6 months
* Expected to receive a heart transplant within 6 months
* With the exception of the elderly in good mental health, all vulnerable subjects as defined by the FDA Office of Human Research Protection or local IRB will be excluded
Inclusion Criteria: - Case-matched retrospective Control Arm
* Qualifying CIED Implant was replacement with a CRT and TYRX, with or without lead revision/addition
* First un-enrolled patient meeting case-matching criteria in series of patients implanted with a CIED and no TYRX beginning 24 months prior to the date of first TYRX implant at site. If no matching patients in this period, first un-enrolled matching patient implanted with a CIED and no TYRX beginning 24 months prior to the first TYRX implant at site, searching in reverse chronological order
* Had at least one of following by date of enrollment into the study:
1. ≥ 12 months follow-up after Qualifying TYRX Implant
2. Subsequent TYRX Procedure that required opening the generator pocket or implant incision ≤ 12 months after Qualifying TYRX Implant (e.g. battery change, upgrade, lead revision, explant)
3. Death ≤ 12 months after Qualifying CIED Implant
* Survived Qualifying CIED Implant to discharge, died of a CIED infection or Mechanical Complication prior to hospital discharge, or died for any reason un-related to Qualifying CIED Implant prior to hospital discharge
* 18 years or older
Exclusion Criteria: - Case-matched retrospective Control Arm
* Contraindication to receiving the TYRX device, in accordance with the package labeling
* Pregnant or became pregnant in the 30 day period following the Qualifying TYRX Implant.
* CIED infection, or the indication for Qualifying CIED Implant was replacement of CIED that was explanted for infection
* Clinical diagnosis of an active infection at the time of Qualifying CIED Implant, including pneumonia, urinary tract infection, endovascular, cellulitis, bacteremia, or other major systemic infection (Note: asymptomatic bacteriuria without UTI is not an exclusion criterion)
* Lead extraction was performed at the Qualifying CIED Implant
* Participated in another clinical study evaluating a drug or device intended to reduce CIED infections
* Received a heart transplant within 6 months of Qualifying CIED Implant
* With the exception of the elderly in good mental health, all vulnerable subjects as defined by the FDA Office of Human Research Protection or local IRB will be excluded
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01043705
Study Brief:
Protocol Section:
NCT01043705