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Completed Phase 4 Interventional Accepts healthy volunteers Results available

World-wide Randomized Antibiotic Envelope Infection Prevention Trial

ClinicalTrials.gov ID: NCT02277990

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.

ClinicalTrials.gov public records Last synced Jun 27, 2026, 7:37 AM EDT

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

Study identification

NCT ID
NCT02277990
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Medtronic Cardiac Rhythm and Heart Failure
Industry
Enrollment
7,075 participants

Conditions and interventions

Interventions

  • TYRX™ Absorbable Antibacterial Envelope Device

Device

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
Dec 31, 2014
Primary completion
Aug 31, 2018
Completion
Aug 31, 2018
Last update posted
Nov 4, 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 4, 2019 · Synced Jun 27, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02277990 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →