World-wide Randomized Antibiotic Envelope Infection Prevention Trial
Public ClinicalTrials.gov record NCT02277990. 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
Cardiac Implantable Electronic Device (CIED) Antibiotic Envelope Infection Prevention Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Medtronic , Inc. is sponsoring the World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT), a randomized, prospective, multi-center, single blinded, post-market, interventional clinical study. This study will evaluate the ability of the TYRX™ envelope to reduce major Cardiac Implantable Electronic Device (CIED) infections through 12-months post-procedure following CIED generator replacement, upgrade, revision, or de novo cardiac resynchronization therapy defibrillator (CRT-D) implant. Additionally, this large device study provides the unique opportunity to prospectively characterize the performance of Medtronic's lead monitoring features in subjects whose CIED system includes a transvenous right ventricular (RV) defibrillation lead. Finally, the WRAP-IT study will serve as a post-approval study for those geographies requiring a post-approval study of the TYRX™ envelope.
Study identification
- NCT ID
- NCT02277990
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 7,075 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2015 (Actual)
- Primary completion
- Sep 2018 (Actual)
- Completion
- Sep 2018 (Actual)
- Last update posted
- Nov 5, 2019
2015 – 2018
United States locations
- U.S. sites
- 120
- U.S. states
- 36
- U.S. cities
- 97
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alaska Heart Institute | Anchorage | Alaska | — | — |
| Tri-City Cardiology Consultants | Mesa | Arizona | — | — |
| Arizona Arrhythmia Consultants | Scottsdale | Arizona | — | — |
| Chula Vista Cardiac Center | Chula Vista | California | — | — |
| Cardiovascular Consultants Heart Center | Fresno | California | — | — |
| UCSD Medical Center | La Jolla | California | — | — |
| Eisenhower Desert Cardiology Center | Rancho Mirage | California | — | — |
| University of California San Francisco UCSF Medical Center | San Francisco | California | — | — |
| Stanford Hospital & Clinics | Stanford | California | — | — |
| Saint Joseph's Medical Center | Stockton | California | — | — |
| Penrose St. Francis Hospital | Colorado Springs | Colorado | — | — |
| Swedish Medical Center | Englewood | Colorado | — | — |
| SCL Physicians Heart Institute of Colorado | Lafayette | Colorado | — | — |
| Danbury Hospital | Danbury | Connecticut | — | — |
| Hartford Hospital | Hartford | Connecticut | — | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | — | — |
| Florida Electrophysiology Associates | Atlantis | Florida | — | — |
| Clearwater Cardiovascular & Interventional Consultants | Clearwater | Florida | — | — |
| The Cardiac & Vascular Institute | Gainesville | Florida | — | — |
| University of Florida Health Shands Hospital | Gainesville | Florida | — | — |
| Kootenai Heart Clinics Northwest | Coeur d'Alene | Idaho | — | — |
| NorthShore University Health System | Evanston | Illinois | — | — |
| Loyola University Medical Center | Maywood | Illinois | — | — |
| Prairie Education & Research Cooperative (Springfield IL) | Springfield | Illinois | — | — |
| Saint Vincent Medical Group | Indianapolis | Indiana | — | — |
| Iowa Heart Center | West Des Moines | Iowa | — | — |
| The University Kansas Medical Center Research Institute Inc | Kansas City | Kansas | — | — |
| Lexington Cardiac Research Foundation | Lexington | Kentucky | — | — |
| Norton Cardiovascular Associates | Louisville | Kentucky | — | — |
| Cardiovascular Research Foundation of Louisiana | Baton Rouge | Louisiana | — | — |
| Advanced Cardiovascular Specialists | Shreveport | Louisiana | — | — |
| Maine Medical Center | Scarborough | Maine | — | — |
| MedStar Health Research Institute | Baltimore | Maryland | — | — |
| Sinai Hospital of Baltimore | Baltimore | Maryland | — | — |
| Delmarva Heart Research Foundation Inc | Salisbury | Maryland | — | — |
| Massachusetts General Hospital | Boston | Massachusetts | — | — |
| University of Michigan | Ann Arbor | Michigan | — | — |
| Sparrow Clinical Research Institute | Lansing | Michigan | — | — |
| DLP Marquette Physicians Practices Inc | Marquette | Michigan | — | — |
| Upper Michigan Cardiovascular Associates PC | Marquette | Michigan | — | — |
| Beaumont Hospital - Royal Oak | Royal Oak | Michigan | — | — |
| Great Lakes Heart and Vascular Institute PC | Saint Joseph | Michigan | — | — |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | — | — |
| University of Minnesota Medical Center | Minneapolis | Minnesota | — | — |
| North Memorial Heart and Vascular Institute | Robbinsdale | Minnesota | — | — |
| Mayo Clinic | Rochester | Minnesota | — | — |
| CentraCare Heart & Vascular Center | Saint Cloud | Minnesota | — | — |
| United Heart and Vascular Clinic | Saint Paul | Minnesota | — | — |
| Hattiesburg Clinic/ Forrest General | Hattiesburg | Mississippi | — | — |
| Mid America Heart Institute (MAHI) | Kansas City | Missouri | — | — |
| Mercy Hospital Springfield | Springfield | Missouri | — | — |
| Saint Anthonys Medical Center | St Louis | Missouri | — | — |
| Washington University School of Medicine | St Louis | Missouri | — | — |
| University of Nebraska | Omaha | Nebraska | — | — |
| Englewood Hospital & Medical Center | Englewood | New Jersey | — | — |
| Jersey Shore University Medical Center | Neptune City | New Jersey | — | — |
| Robert Wood Johnson Medical School | New Brunswick | New Jersey | — | — |
| The Valley Hospital | Ridgewood | New Jersey | — | — |
| Lourdes Cardiology Services | Voorhees Township | New Jersey | — | — |
| Saint Joseph's Hospital Health Center | Liverpool | New York | — | — |
| Cornell University Medical Center | New York | New York | — | — |
| Mount Sinai Saint Luke's Hospital | New York | New York | — | — |
| New York Presbyterian Hospital | New York | New York | — | — |
| NYU | New York | New York | — | — |
| University of Rochester Medical Center | Rochester | New York | — | — |
| Westchester Medical Center | Valhalla | New York | — | — |
| Asheville Cardiology Associate PA | Asheville | North Carolina | — | — |
| Novant Health Heart and Vascular Institute | Charlotte | North Carolina | — | — |
| Duke University Medical Center (DUMC) | Durham | North Carolina | — | — |
| Raleigh Cardiology Associates | Raleigh | North Carolina | — | — |
| Novant Health Forsyth Medical Center | Winston-Salem | North Carolina | — | — |
| Wake Forest University Health Sciences / Baptist Medical Center / North Carolina Baptist Hospital | Winston-Salem | North Carolina | — | — |
| Akron General Medical Center | Akron | Ohio | — | — |
| Northeast Ohio Cardiovascular Specialists | Akron | Ohio | — | — |
| The Lindner Research Center | Cincinnati | Ohio | — | — |
| Cleveland Clinic | Cleveland | Ohio | — | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | — | — |
| OhioHealth Riverside Methodist Hospital | Columbus | Ohio | — | — |
| The Ohio State University | Columbus | Ohio | — | — |
| Saint Elizabeth Health Center | Poland | Ohio | — | — |
| Mount Carmel East | Westerville | Ohio | — | — |
| Oklahoma Heart Hospital Research Foundation | Oklahoma City | Oklahoma | — | — |
| University of Oklahoma Health Science Center (OUHSC) | Oklahoma City | Oklahoma | — | — |
| Oklahoma Heart Institute | Tulsa | Oklahoma | — | — |
| Legacy Medical Group | Portland | Oregon | — | — |
| Oregon Health & Science University Hospital | Portland | Oregon | — | — |
| Providence Health & Services | Portland | Oregon | — | — |
| Lehigh Valley Hospital Cedar Crest | Allentown | Pennsylvania | — | — |
| Saint Luke's Hospital | Bethlehem | Pennsylvania | — | — |
| Geisinger Medical Center | Danville | Pennsylvania | — | — |
| Doylestown Cardiology Associates - VIAA | Doylestown | Pennsylvania | — | — |
| University of Pittsburgh Medical Center UPMC Hamot | Erie | Pennsylvania | — | — |
| Saint Mary Medical Center (Langhorne PA) | Newtown | Pennsylvania | — | — |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | — | — |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | — | — |
| Temple University Hospital | Philadelphia | Pennsylvania | — | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | — | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | — | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | — | — |
| University of Pittsburgh Medical Center UPMC Presbyterian | Pittsburgh | Pennsylvania | — | — |
| The Miriam Hospital | East Providence | Rhode Island | — | — |
| The Stern Cardiovascular Foundation | Germantown | Tennessee | — | — |
| Jackson Clinic | Jackson | Tennessee | — | — |
| Wellmont CVA Heart Institute | Kingsport | Tennessee | — | — |
| Centennial Heart Cardiovascular Consultants LLC | Nashville | Tennessee | — | — |
| Saint Thomas Research Institute | Nashville | Tennessee | — | — |
| Amarillo Heart Group | Amarillo | Texas | — | — |
| Cardiology Associates of Corpus Christi | Corpus Christi | Texas | — | — |
| Baylor Heart & Vascular Hospital | Dallas | Texas | — | — |
| North Texas Heart Center | Dallas | Texas | — | — |
| Plaza Medical Center of Fort Worth | Fort Worth | Texas | — | — |
| Longview Regional Medical Center | Longview | Texas | — | — |
| Baylor Research Institute | Plano | Texas | — | — |
| Scott & White Health Science Ctr | Temple | Texas | — | — |
| EP Heart LLC | The Woodlands | Texas | — | — |
| The University of Vermont Medical Center Inc | Burlington | Vermont | — | — |
| Virginia Commonwealth University Health System | Richmond | Virginia | — | — |
| Saint Mary's Medical Center | Huntington | West Virginia | — | — |
| Aurora BayCare Medical Center | Green Bay | Wisconsin | — | — |
| Bellin Memorial Hospital, Inc. | Green Bay | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 61 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02277990, 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 Nov 5, 2019 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02277990 live on ClinicalTrials.gov.