World-wide Randomized Antibiotic Envelope Infection Prevention Trial

PHASE4CompletedINTERVENTIONAL
Enrollment

7,075

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

September 30, 2018

Study Completion Date

September 30, 2018

Conditions
CIED Related Infection
Interventions
DEVICE

TYRX™ Absorbable Antibacterial Envelope

Trial Locations (181)

Unknown

Alaska Heart Institute, Anchorage

Tri-City Cardiology Consultants, Mesa

Arizona Arrhythmia Consultants, Scottsdale

Chula Vista Cardiac Center, Chula Vista

Cardiovascular Consultants Heart Center, Fresno

UCSD Medical Center, La Jolla

Eisenhower Desert Cardiology Center, Rancho Mirage

University of California San Francisco UCSF Medical Center, San Francisco

Stanford Hospital & Clinics, Stanford

Saint Joseph's Medical Center, Stockton

Penrose St. Francis Hospital, Colorado Springs

Swedish Medical Center, Englewood

SCL Physicians Heart Institute of Colorado, Lafayette

Danbury Hospital, Danbury

Hartford Hospital, Hartford

MedStar Washington Hospital Center, Washington D.C.

Florida Electrophysiology Associates, Atlantis

Clearwater Cardiovascular & Interventional Consultants, Clearwater

The Cardiac & Vascular Institute, Gainesville

University of Florida Health Shands Hospital, Gainesville

Kootenai Heart Clinics Northwest, Coeur d'Alene

NorthShore University Health System, Evanston

Loyola University Medical Center, Maywood

Prairie Education & Research Cooperative (Springfield IL), Springfield

Saint Vincent Medical Group, Indianapolis

Iowa Heart Center, West Des Moines

The University Kansas Medical Center Research Institute Inc, Kansas City

Lexington Cardiac Research Foundation, Lexington

Norton Cardiovascular Associates, Louisville

Cardiovascular Research Foundation of Louisiana, Baton Rouge

Advanced Cardiovascular Specialists, Shreveport

Maine Medical Center, Scarborough

MedStar Health Research Institute, Baltimore

Sinai Hospital of Baltimore, Baltimore

Delmarva Heart Research Foundation Inc, Salisbury

Massachusetts General Hospital, Boston

University of Michigan, Ann Arbor

Sparrow Clinical Research Institute, Lansing

DLP Marquette Physicians Practices Inc, Marquette

Upper Michigan Cardiovascular Associates PC, Marquette

Beaumont Hospital - Royal Oak, Royal Oak

Great Lakes Heart and Vascular Institute PC, Saint Joseph

Minneapolis Heart Institute Foundation, Minneapolis

University of Minnesota Medical Center, Minneapolis

North Memorial Heart and Vascular Institute, Robbinsdale

Mayo Clinic, Rochester

CentraCare Heart & Vascular Center, Saint Cloud

United Heart and Vascular Clinic, Saint Paul

Hattiesburg Clinic/ Forrest General, Hattiesburg

Mid America Heart Institute (MAHI), Kansas City

Mercy Hospital Springfield, Springfield

Saint Anthonys Medical Center, St Louis

Washington University School of Medicine, St Louis

University of Nebraska, Omaha

Englewood Hospital & Medical Center, Englewood

Jersey Shore University Medical Center, Neptune City

Robert Wood Johnson Medical School, New Brunswick

The Valley Hospital, Ridgewood

Lourdes Cardiology Services, Voorhees Township

Saint Joseph's Hospital Health Center, Liverpool

Cornell University Medical Center, New York

Mount Sinai Saint Luke's Hospital, New York

New York Presbyterian Hospital, New York

NYU, New York

University of Rochester Medical Center, Rochester

Westchester Medical Center, Valhalla

Asheville Cardiology Associate PA, Asheville

Novant Health Heart and Vascular Institute, Charlotte

Duke University Medical Center (DUMC), Durham

Raleigh Cardiology Associates, Raleigh

Novant Health Forsyth Medical Center, Winston-Salem

Wake Forest University Health Sciences / Baptist Medical Center / North Carolina Baptist Hospital, Winston-Salem

Akron General Medical Center, Akron

Northeast Ohio Cardiovascular Specialists, Akron

The Lindner Research Center, Cincinnati

Cleveland Clinic, Cleveland

University Hospitals Case Medical Center, Cleveland

OhioHealth Riverside Methodist Hospital, Columbus

The Ohio State University, Columbus

Saint Elizabeth Health Center, Poland

Mount Carmel East, Westerville

Oklahoma Heart Hospital Research Foundation, Oklahoma City

University of Oklahoma Health Science Center (OUHSC), Oklahoma City

Oklahoma Heart Institute, Tulsa

Legacy Medical Group, Portland

Oregon Health & Science University Hospital, Portland

Providence Health & Services, Portland

Lehigh Valley Hospital Cedar Crest, Allentown

Saint Luke's Hospital, Bethlehem

Geisinger Medical Center, Danville

Doylestown Cardiology Associates - VIAA, Doylestown

University of Pittsburgh Medical Center UPMC Hamot, Erie

Saint Mary Medical Center (Langhorne PA), Newtown

Drexel University College of Medicine, Philadelphia

Pennsylvania Hospital, Philadelphia

Temple University Hospital, Philadelphia

Thomas Jefferson University Hospital, Philadelphia

University of Pennsylvania, Philadelphia

Allegheny General Hospital, Pittsburgh

University of Pittsburgh Medical Center UPMC Presbyterian, Pittsburgh

The Miriam Hospital, East Providence

The Stern Cardiovascular Foundation, Germantown

Jackson Clinic, Jackson

Wellmont CVA Heart Institute, Kingsport

Centennial Heart Cardiovascular Consultants LLC, Nashville

Saint Thomas Research Institute, Nashville

Amarillo Heart Group, Amarillo

Cardiology Associates of Corpus Christi, Corpus Christi

Baylor Heart & Vascular Hospital, Dallas

North Texas Heart Center, Dallas

Plaza Medical Center of Fort Worth, Fort Worth

Longview Regional Medical Center, Longview

Baylor Research Institute, Plano

Scott & White Health Science Ctr, Temple

EP Heart LLC, The Woodlands

The University of Vermont Medical Center Inc, Burlington

Virginia Commonwealth University Health System, Richmond

Saint Mary's Medical Center, Huntington

Aurora BayCare Medical Center, Green Bay

Bellin Memorial Hospital, Inc., Green Bay

Universitätsklinikum Krems, Krems

Universitair Ziekenhuis Brussel, Brussels

Ziekenhuis Oost Limburg - Campus St.-Jan, Genk

Centre Hospitalier Regional de la Citadelle, Liège

Saint Paul's Hospital (Vancouver BC), Vancouver

Hamilton General Hospital / Hamilton Health Sciences, Hamilton

University of Ottawa Heart Institute, Ottawa

Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ), Québec

Hospital San Juan de Dios, Santiago

Grantham Hospital, Hong Kong

Princess Margaret Hospital, Hong Kong

Rigshospitalet, Copenhagen

Helsinki University Hospital, Helsinki

Turun Yliopistollinen keskussairaala, Turku

Centre Hospitalier Régional Universitaire de Lille, Lille

Hôpital de la Timone - Centre Hospitalier Universitaire de Marseille, Marseille

Nouvelles Cliniques Nantaises, Nantes

CHU Hôpiteaux de Rouen - Hôpital Charles Nicolle, Rouen

Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord, Saint-Priest-en-Jarez

Universitäts-Herz-Zentrum Freiburg - Bad Krozingen, Bad Krozingen

Universitätsmedizin Rostock, Rostock

University General Hospital of Heraklion, Heraklion

University Hospital of Ioannina, Ioannina

Onassis Cardiac Surgery Center, Kallithea

Rabin Medical Center - Beilinson Hospital, Petah Tikva

Chaim Sheba Medical Center, Ramat Gan

Policlinico Sant' Orsola - Malpighi, Bologna

Azienda Ospedaliera Spedali Civili di Brescia, Brescia

Presidio Ospedaliero Sant'Anna, Como

Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello, Pisa

Hospital Sultanah Bahiyah, Alor Star

Institut Jantung Negara - National Heart Institute, Kuala Lumpur

Universiti Malaya Medical Centre, Kuala Lumpur

Catharina Ziekenhuis, Eindhoven

St. Antonius Ziekenhuis, Nieuwegein

Helse Bergen HF - Haukeland Universitetssjukehus, Bergen

Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Lublin

Szpital Kliniczny Przemienienia Panskiego, Poznan

Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE, Lisbon

Centro Hospitalar do Porto, Porto

King Faisal Specialist Hospital & Research Center, Riyadh

Changi General Hospital, Singapore

National Heart Centre Singapore, Singapore

Stredoslovensky ustav srdcovych a cievnych chorob a.s, Banská Bystrica

Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH), Bratislava

Vychodoslovensky ustav srdcovych a cievnych chorob, a.s., Košice

Hospital Marqués de Valdecilla, Santander

Hospital Universitari Bellvitge, Barcelona

Hospital Universitario La Paz, Madrid

Hospital Universitario Ramón y Cajal, Madrid

Alingsås Lasarett, Gothenburg

Sahlgrenska Universitetssjukhuset, Gothenburg

Karolinska Universitetssjukhuset, Stockholm

Sjukhuset i Varberg, Varberg

Centre Hospitalier Universitaire Vaudois, Lausanne

Cardiocentro Ticino, Lugano

Kantonsspital St.Gallen, Sankt Gallen

Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool

Royal Brompton & Harefield NHS Foundation Trust - Harefield Hospital, London

Central Manchester University Hospitals NHS - Manchester Royal Infirmary, Manchester

The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital, Newcastle upon Tyne

All Listed Sponsors
collaborator

The Cleveland Clinic

OTHER

lead

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

NCT02277990 - World-wide Randomized Antibiotic Envelope Infection Prevention Trial | Biotech Hunter | Biotech Hunter