TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD
Public ClinicalTrials.gov record NCT01043705. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Centurion and Citadel Studies of TYRX™ Anti-Bacterial Envelope and Custom Mesh for Prevention of Infection Following CIED Replacement With a CRT or ICD
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to compare the incidence of cardiac implantable electronic device (CIED) infection and CIED mechanical complication after CIED replacement with a high-power cardiac implantable electronic device; either a cardiac resynchronization therapy device (CRT), or an implantable cardioverter defibrilator (ICD) and TYRX Anti-Bacterial Envelope (formerly known as "AIGISRx"), to the incidence, after replacement with an ICD or CRT and no TYRX.
Study identification
- NCT ID
- NCT01043705
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 1,262 participants
Conditions and interventions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2010 (Type not available)
- Primary completion
- Jul 2014 (Actual)
- Completion
- May 2015 (Actual)
- Last update posted
- Dec 24, 2015
2010 – 2015
United States locations
- U.S. sites
- 52
- U.S. states
- 22
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Princeton Medical Center | Birmingham | Alabama | 35211 | — |
| Decatur General Hospital | Decatur | Alabama | 35601 | — |
| Eliza Coffee Memorial Hospital | Florence | Alabama | 35630 | — |
| Riverview Regional Hospital | Gadsden | Alabama | 35901 | — |
| Arizona Heart Hospital | Scottsdate | Arizona | 85251 | — |
| Community Memorial Hospital | Ventura | California | 93003 | — |
| Watsonville Community Hospital | Watsonville | California | 95076 | — |
| Citrus Memorial Hospital | Inverness | Florida | 34452 | — |
| Osceola Regional Medical Center | Kissimmee | Florida | 34741 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Orlando Regional Hospital | Orlando | Florida | 32806 | — |
| Tallahassee Memorial Hospital | Tallahassee | Florida | 32308 | — |
| Piedmont Medical Center | Atlanta | Georgia | 30309 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| Veteran's Administration Medical Center | Atlanta | Georgia | 30345 | — |
| Wellstar Kennestone Hospital | Marietta | Georgia | 30060 | — |
| Trinity Medical Center | Rock Island | Illinois | 61201 | — |
| St. John's Hospital | Springfield | Illinois | 62769 | — |
| St. Mary's Medical | Hobart | Indiana | 46342 | — |
| Community Hospital, Munster | Munster | Indiana | 46321 | — |
| St. Margaret Mercy | Munster | Indiana | 46321 | — |
| P and S Surgical Hospital | Monroe | Louisiana | 71201 | — |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Johns Hopkins University Hospital | Baltimore | Maryland | 21205 | — |
| Penninsula Regional Medical Center | Salisbury | Maryland | 21804 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02144 | — |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Sparrow Hospital | Lansing | Michigan | 48910 | — |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | — |
| Gulfport Memorial Hospital | Biloxi | Mississippi | 39532 | — |
| Keesler Air Force Base Hospital | Biloxi | Mississippi | 39534 | — |
| Southern Heart Center | Hattiesburg | Mississippi | 39401 | — |
| Alegent Health | Omaha | Nebraska | 68124 | — |
| Englewood Hospital and Medical Center | Englewood | New Jersey | 07631 | — |
| St. Francis Hospital | Hamilton | New Jersey | 08690 | — |
| Newark Beth Israel Hospital | Newark | New Jersey | 07112 | — |
| Valley Hospital | Ridgewood | New Jersey | 07450 | — |
| Our Lady of Lourdes Hospital | Sewell | New Jersey | 08080 | — |
| St. Luke's - Roosevelt Hospital | New York | New York | 10025 | — |
| Frye Regional Medical Center | Hickory | North Carolina | 28601 | — |
| Catholic Health Partners | Youngstown | Ohio | 44510 | — |
| Doylestown Hospital | Doylestown | Pennsylvania | 18901 | — |
| Pinnacle Health Harrisburg Hospital | Harrisburg | Pennsylvania | 17110 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| York Hospital | York | Pennsylvania | 17403 | — |
| Landmark Medical Center | Woonsocket | Rhode Island | 02895 | — |
| Stern Cardiovascular Foundation | Germantown | Tennessee | 38138 | — |
| University of Tenn. Medical Center - Knoxville | Knoxville | Tennessee | 37920 | — |
| Texas Heart Institute - St. Luke's Episcopal Hospital | Houston | Texas | 77030 | — |
| NE Methodist | San Antonio | Texas | 78258 | — |
| Aurora Health Care | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01043705, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 24, 2015 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01043705 live on ClinicalTrials.gov.