Please assess the completion status of the following clinical trial:

Trial Title: TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD

Study Design Characteristics:
- Allocation: None
- Intervention Model: None
- Observational Model: CASE_CONTROL
- Primary Purpose: None
- Time Perspective: PROSPECTIVE
- Masking: None
- Phase: None
- Number of Arms: None

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

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- CIED replacement with CRT and TYRX (Type: None): (Prospective Arm) Patients who have undergone CIED replacement with a CRT and the TYRX Anti-bacterial envelope, with or without lead revision.
- CIED replacement with ICD and TYRX (Type: None): (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 ICD or CRT and TYRX (Type: None): (Prospective Arm) Patients who have undergone CIED replacement with an ICD or CRT and the TYRX Anti-bacterial envelope, with or without lead revision.
- CIED replacement w/ CRT & no TYRX (Type: None): (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 w/ CRT & TYRX vs. Case Match Arm (Type: None): Patients who have undergone CIED replacement with a CRT and TYRX Anti-bacterial envelope, with or without lead revision/addition. Cohort is TYRX Case, Matched to Retrospective Case-Control Arm)

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete