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CIED Related InfectionPhase 4WRAP-ITNCT02277990

World-wide Randomized Antibiotic Envelope Infection Prevention Trial

A Phase 4 study testing TYRX™ Absorbable Antibacterial Envelope in people with CIED Related Infection, run by Medtronic Cardiac Rhythm and Heart Failure at 181 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
CIED Related Infection
What is being tested?
TYRX™ Absorbable Antibacterial Envelope
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,075 participants
Where
181 sitesin 25 countries
Study dates
Jan 2015to Sep 2018
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patient is willing to sign and date the study patient informed consent (PIC) form
  • Patient is at least 18 years of age and meets age requirements per local law
  • Patient is planned to undergo at least one of the following:
  • Patient has existing cardiac implantable electronic device (CIED) and is undergoing implantable pulse generator (IPG) (including cardiac resynchronization therapy pacemaker [CRT-P]), implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) replacement or upgrade with a new Medtronic generator
  • Subjects planned to have leads added, or extracted and added for upgrades can be enrolled OR
  • Patient will undergo a de novo Medtronic CRT-D system implant per approved indications
Show all 10Show fewer
  • OR
  • Patient has existing study eligible Medtronic CIED in which the pocket was not accessed within the last 365 days, and is undergoing pocket or lead revision
  • Willing to provide the contact information for the physician who provides followup for his/her CIED
  • Willing and able to comply with scheduled follow-up and study related activities

Who cannot join

  • Known allergy to minocycline or rifampin or their derivatives, or any other known contraindications to implantation of the TYRX envelope.
  • Current therapy with chronic oral immunosuppressive agents or ≥ 20mg/day of Prednisone or equivalent.
  • Hemodialysis or peritoneal dialysis.
  • Prior Cardiac transplantation or existing Ventricular Assist Device (VAD).
  • Require long-term vascular access for any reason.
  • Prior history of a CIED infection, other prosthetic device infection, or endovascular infection, including endocarditis, in the past 12 months.
Show all 10Show fewer
  • Physical, clinical, or laboratory signs or symptoms consistent with an active infection (including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia)
  • Systemic lupus erythematous, because minocycline has been reported to aggravate this condition
  • Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within 7 days prior to device procedure
  • Participation in another study that may confound the results of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.

Trial locations and contacts

181 sites in 25 countries.

181 sites in 25 countries

United States120 sites

  • Akron General Medical Center

    Akron, Ohio

  • Northeast Ohio Cardiovascular Specialists

    Akron, Ohio

  • Lehigh Valley Hospital Cedar Crest

    Allentown, Pennsylvania

  • Amarillo Heart Group

    Amarillo, Texas

  • Alaska Heart Institute

    Anchorage, Alaska

  • University of Michigan

    Ann Arbor, Michigan

  • Asheville Cardiology Associate PA

    Asheville, North Carolina

  • Florida Electrophysiology Associates

    Atlantis, Florida

  • MedStar Health Research Institute

    Baltimore, Maryland

  • Sinai Hospital of Baltimore

    Baltimore, Maryland

  • Cardiovascular Research Foundation of Louisiana

    Baton Rouge, Louisiana

  • Saint Luke's Hospital

    Bethlehem, Pennsylvania

  • Massachusetts General Hospital

    Boston, Massachusetts

  • The University of Vermont Medical Center Inc

    Burlington, Vermont

  • Novant Health Heart and Vascular Institute

    Charlotte, North Carolina

  • Chula Vista Cardiac Center

    Chula Vista, California

  • The Lindner Research Center

    Cincinnati, Ohio

  • Clearwater Cardiovascular & Interventional Consultants

    Clearwater, Florida

  • Cleveland Clinic

    Cleveland, Ohio

  • University Hospitals Case Medical Center

    Cleveland, Ohio

  • Kootenai Heart Clinics Northwest

    Coeur d'Alene, Idaho

  • Penrose St. Francis Hospital

    Colorado Springs, Colorado

  • OhioHealth Riverside Methodist Hospital

    Columbus, Ohio

  • The Ohio State University

    Columbus, Ohio

  • Cardiology Associates of Corpus Christi

    Corpus Christi, Texas

  • Baylor Heart & Vascular Hospital

    Dallas, Texas

  • North Texas Heart Center

    Dallas, Texas

  • Danbury Hospital

    Danbury, Connecticut

  • Geisinger Medical Center

    Danville, Pennsylvania

  • Doylestown Cardiology Associates - VIAA

    Doylestown, Pennsylvania

  • Duke University Medical Center (DUMC)

    Durham, North Carolina

  • The Miriam Hospital

    East Providence, Rhode Island

  • Swedish Medical Center

    Englewood, Colorado

  • Englewood Hospital & Medical Center

    Englewood, New Jersey

  • University of Pittsburgh Medical Center UPMC Hamot

    Erie, Pennsylvania

  • NorthShore University Health System

    Evanston, Illinois

  • Plaza Medical Center of Fort Worth

    Fort Worth, Texas

  • Cardiovascular Consultants Heart Center

    Fresno, California

  • The Cardiac & Vascular Institute

    Gainesville, Florida

  • University of Florida Health Shands Hospital

    Gainesville, Florida

  • The Stern Cardiovascular Foundation

    Germantown, Tennessee

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin

  • Bellin Memorial Hospital, Inc.

    Green Bay, Wisconsin

  • Hartford Hospital

    Hartford, Connecticut

  • Hattiesburg Clinic/ Forrest General

    Hattiesburg, Mississippi

  • Saint Mary's Medical Center

    Huntington, West Virginia

  • Saint Vincent Medical Group

    Indianapolis, Indiana

  • Jackson Clinic

    Jackson, Tennessee

  • The University Kansas Medical Center Research Institute Inc

    Kansas City, Kansas

  • Mid America Heart Institute (MAHI)

    Kansas City, Missouri

  • Wellmont CVA Heart Institute

    Kingsport, Tennessee

  • UCSD Medical Center

    La Jolla, California

  • SCL Physicians Heart Institute of Colorado

    Lafayette, Colorado

  • Sparrow Clinical Research Institute

    Lansing, Michigan

  • Lexington Cardiac Research Foundation

    Lexington, Kentucky

  • Saint Joseph's Hospital Health Center

    Liverpool, New York

  • Longview Regional Medical Center

    Longview, Texas

  • Norton Cardiovascular Associates

    Louisville, Kentucky

  • DLP Marquette Physicians Practices Inc

    Marquette, Michigan

  • Upper Michigan Cardiovascular Associates PC

    Marquette, Michigan

  • Loyola University Medical Center

    Maywood, Illinois

  • Tri-City Cardiology Consultants

    Mesa, Arizona

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota

  • University of Minnesota Medical Center

    Minneapolis, Minnesota

  • Centennial Heart Cardiovascular Consultants LLC

    Nashville, Tennessee

  • Saint Thomas Research Institute

    Nashville, Tennessee

  • Jersey Shore University Medical Center

    Neptune City, New Jersey

  • Robert Wood Johnson Medical School

    New Brunswick, New Jersey

  • 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

  • Saint Mary Medical Center (Langhorne PA)

    Newtown, Pennsylvania

  • Oklahoma Heart Hospital Research Foundation

    Oklahoma City, Oklahoma

  • University of Oklahoma Health Science Center (OUHSC)

    Oklahoma City, Oklahoma

  • University of Nebraska

    Omaha, Nebraska

  • 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

  • Baylor Research Institute

    Plano, Texas

  • Saint Elizabeth Health Center

    Poland, Ohio

  • Legacy Medical Group

    Portland, Oregon

  • Oregon Health & Science University Hospital

    Portland, Oregon

  • Providence Health & Services

    Portland, Oregon

  • Raleigh Cardiology Associates

    Raleigh, North Carolina

  • Eisenhower Desert Cardiology Center

    Rancho Mirage, California

  • Virginia Commonwealth University Health System

    Richmond, Virginia

  • The Valley Hospital

    Ridgewood, New Jersey

  • North Memorial Heart and Vascular Institute

    Robbinsdale, Minnesota

  • Mayo Clinic

    Rochester, Minnesota

  • University of Rochester Medical Center

    Rochester, New York

  • Beaumont Hospital - Royal Oak

    Royal Oak, Michigan

  • CentraCare Heart & Vascular Center

    Saint Cloud, Minnesota

  • Great Lakes Heart and Vascular Institute PC

    Saint Joseph, Michigan

  • United Heart and Vascular Clinic

    Saint Paul, Minnesota

  • Delmarva Heart Research Foundation Inc

    Salisbury, Maryland

  • University of California San Francisco UCSF Medical Center

    San Francisco, California

  • Maine Medical Center

    Scarborough, Maine

  • Arizona Arrhythmia Consultants

    Scottsdale, Arizona

  • Advanced Cardiovascular Specialists

    Shreveport, Louisiana

  • Prairie Education & Research Cooperative (Springfield IL)

    Springfield, Illinois

  • Mercy Hospital Springfield

    Springfield, Missouri

  • Saint Anthonys Medical Center

    St Louis, Missouri

  • Washington University School of Medicine

    St Louis, Missouri

  • Stanford Hospital & Clinics

    Stanford, California

  • Saint Joseph's Medical Center

    Stockton, California

  • Scott & White Health Science Ctr

    Temple, Texas

  • EP Heart LLC

    The Woodlands, Texas

  • Oklahoma Heart Institute

    Tulsa, Oklahoma

  • Westchester Medical Center

    Valhalla, New York

  • Lourdes Cardiology Services

    Voorhees Township, New Jersey

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia

  • Iowa Heart Center

    West Des Moines, Iowa

  • Mount Carmel East

    Westerville, Ohio

  • 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

Other trials in United States

France5 sites

  • 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

Other trials in France

Canada4 sites

  • Hamilton General Hospital / Hamilton Health Sciences

    Hamilton, Ontario

  • University of Ottawa Heart Institute

    Ottawa, Ontario

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

    Québec

  • Saint Paul's Hospital (Vancouver BC)

    Vancouver, British Columbia

Other trials in Canada

Italy4 sites

  • 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

Other trials in Italy

Spain4 sites

  • Hospital Universitari Bellvitge

    Barcelona

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Ramón y Cajal

    Madrid

  • Hospital Marqués de Valdecilla

    Santander, Cantabria

Other trials in Spain

Sweden4 sites

  • Alingsås Lasarett

    Gothenburg

  • Sahlgrenska Universitetssjukhuset

    Gothenburg

  • Karolinska Universitetssjukhuset

    Stockholm

  • Sjukhuset i Varberg

    Varberg

Other trials in Sweden

United Kingdom4 sites

  • 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

Other trials in United Kingdom

Belgium3 sites

  • Universitair Ziekenhuis Brussel

    Brussels

  • Ziekenhuis Oost Limburg - Campus St.-Jan

    Genk

  • Centre Hospitalier Regional de la Citadelle

    Liège

Other trials in Belgium

Greece3 sites

  • University General Hospital of Heraklion

    Heraklion

  • University Hospital of Ioannina

    Ioannina

  • Onassis Cardiac Surgery Center

    Kallithea

Other trials in Greece

Malaysia3 sites

  • Hospital Sultanah Bahiyah

    Alor Star, Kedah

  • Institut Jantung Negara - National Heart Institute

    Kuala Lumpur

  • Universiti Malaya Medical Centre

    Kuala Lumpur

Other trials in Malaysia

Slovakia3 sites

  • 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

Other trials in Slovakia

Switzerland3 sites

  • Centre Hospitalier Universitaire Vaudois

    Lausanne

  • Cardiocentro Ticino

    Lugano

  • Kantonsspital St.Gallen

    Sankt Gallen

Other trials in Switzerland

China2 sites

  • Grantham Hospital

    Hong Kong

  • Princess Margaret Hospital

    Hong Kong

Other trials in China

Finland2 sites

  • Helsinki University Hospital

    Helsinki

  • Turun Yliopistollinen keskussairaala

    Turku

Other trials in Finland

Germany2 sites

  • Universitäts-Herz-Zentrum Freiburg - Bad Krozingen

    Bad Krozingen

  • Universitätsmedizin Rostock

    Rostock

Other trials in Germany

Israel2 sites

  • Rabin Medical Center - Beilinson Hospital

    Petah Tikva

  • Chaim Sheba Medical Center

    Ramat Gan

Other trials in Israel

Netherlands2 sites

  • Catharina Ziekenhuis

    Eindhoven

  • St. Antonius Ziekenhuis

    Nieuwegein

Other trials in Netherlands

Poland2 sites

  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

    Lublin

  • Szpital Kliniczny Przemienienia Panskiego

    Poznan

Other trials in Poland

Portugal2 sites

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

    Lisbon

  • Centro Hospitalar do Porto

    Porto

Other trials in Portugal

Singapore2 sites

  • Changi General Hospital

    Singapore

  • National Heart Centre Singapore

    Singapore

Other trials in Singapore

Austria1 site

  • Universitätsklinikum Krems

    Krems

Other trials in Austria

Chile1 site

  • Hospital San Juan de Dios

    Santiago

Other trials in Chile

Denmark1 site

  • Rigshospitalet

    Copenhagen

Other trials in Denmark

Norway1 site

  • Helse Bergen HF - Haukeland Universitetssjukehus

    Bergen

Other trials in Norway

Saudi Arabia1 site

  • King Faisal Specialist Hospital & Research Center

    Riyadh

Other trials in Saudi Arabia

About this study

Official title: Cardiac Implantable Electronic Device (CIED) Antibiotic Envelope Infection Prevention Trial

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.

Being tested
TYRX™ Absorbable Antibacterial Envelope

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TYRX™ Absorbable Antibacterial EnvelopeDevice

Study groups in NCT02277990
Study groupRoleWhat they receive
TYRX™ envelopeActive comparatorThe Medtronic TYRX™ Absorbable Antibacterial Envelope is an absorbable sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. The purpose of the absorbable coating is to act as a carrier for the antimicrobial agents.
Receives: Device: TYRX™ Absorbable Antibacterial Envelope
ControlNo interventionNo TYRX™ envelope, bare CIED

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 12 Month Kaplan-Meier Estimate of Major CIED Infection Rate

    CIED infections are defined as (1) superficial cellulitis in the region of the CIED pocket with wound dehiscence, erosion, or purulent drainage, (2) deep incisional or organ/space (generator pocket) surgical site infection that meets the Centers for Disease Control and Prevention criteria, independent from time of surgery, (3) persistent bacteremia, or (4) endocarditis.

    Major CIED infections are defined as a CIED infection resulting in one or more of the following:

    • CIED system removal
    • Any invasive procedure (e.g. pocket opened) without system removal
    • Treatment with antibiotic therapy if the subject is not a candidate for system removal and infection recurrence after completion of antibiotic therapy or evidence of deep infection with wound dehiscence, erosion, or purulent drainage
    • Death

    Measured: Implant to 12 months

Secondary outcomes (3)

  1. 12 Month Kaplan-Meier Estimate of Major or Minor CIED Infection

    Major CIED infections are defined above. Minor CIED infections are defined as CIED infections that do not meet the definition of a major CIED infection

    Measured: Implant to 12 months

  2. 12 Month Kaplan-Meier Estimate of a CIED Procedure Related or System Related Complication

    • A CIED system related event is defined as an adverse event related to the CIED system which includes the device, leads, implant tool(s), programmer, or TYRX envelope (if applicable)
    • A CIED procedure related event is defined as an adverse event that occurs due to any procedure related to the implantation or surgical modification of the system including the TYRX envelope (if applicable)
    • A procedure or system related complication is defined as an adverse event related to a CIED procedure or the CIED system that results in at least one of the following:

    Death,Termination of significant device function, Invasive intervention

    Measured: Implant to 12 months

  3. Kaplan-Meier Estimate of a Major Infection Throughout Follow-up

    CIED infections are defined as (1) superficial cellulitis in the region of the CIED pocket with wound dehiscence, erosion, or purulent drainage, (2) deep incisional or organ/space (generator pocket) surgical site infection that meets the Centers for Disease Control and Prevention criteria, independent from time of surgery, (3) persistent bacteremia, or (4) endocarditis.

    Major CIED infections are defined as a CIED infection resulting in one or more of the following:

    • CIED system removal
    • Any invasive procedure (e.g. pocket opened) without system removal
    • Treatment with antibiotic therapy if the subject is not a candidate for system removal and infection recurrence after completion of antibiotic therapy or evidence of deep infection with wound dehiscence, erosion, or purulent drainage
    • Death

    Measured: Throughout study follow-up Kaplan-Meier Estimate is at 36 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionSep 2018
  4. Study completionSep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
7,075 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02277990
Sponsor's protocol ID
WRAP-IT
Acronym
WRAP-IT
Status last verified
Oct 2019
First submitted
22 Oct 2014
Last updated
5 Nov 2019
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Poole JE, Swerdlow CD, Tarakji KG, Mittal S, Ellenbogen KA, Greenspon AJ, Kennergren C, Philbert BT, Moore J, Jones RC, Schaller RD, Hansalia R, Simmers T, Mihalcz A, DeBus B, Lexcen DR, Gunderson B, Wilkoff BL. Clinical performance of implantable cardioverter-defibrillator lead monitoring diagnostics. Heart Rhythm. 2022 Mar;19(3):363-371. doi: 10.1016/j.hrthm.2021.10.032. Epub 2021 Nov 9.

    PubMed 34767985

  • Sohail MR, Corey GR, Wilkoff BL, Poole JE, Mittal S, Kennergren C, Greenspon AJ, Cheng A, Lande JD, Lexcen DR, Tarakji KG. Clinical Presentation, Timing, and Microbiology of CIED Infections: An Analysis of the WRAP-IT Trial. JACC Clin Electrophysiol. 2021 Jan;7(1):50-61. doi: 10.1016/j.jacep.2020.07.021. Epub 2020 Oct 28.

    PubMed 33478712

  • Wilkoff BL, Boriani G, Mittal S, Poole JE, Kennergren C, Corey GR, Krahn AD, Schloss EJ, Gallastegui JL, Pickett RA, Evonich RF, Roark SF, Sorrentino DM, Sholevar DP, Cronin EM, Berman BJ, Riggio DW, Khan HH, Silver MT, Collier J, Eldadah Z, Holbrook R, Lande JD, Lexcen DR, Seshadri S, Tarakji KG. Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial. Circ Arrhythm Electrophysiol. 2020 Oct;13(10):e008503. doi: 10.1161/CIRCEP.120.008503. Epub 2020 Sep 11.

    PubMed 32915063

  • Wilkoff BL, Boriani G, Mittal S, Poole JE, Kennergren C, Corey GR, Love JC, Augostini R, Faerestrand S, Wiggins SS, Healey JS, Holbrook R, Lande JD, Lexcen DR, Willey S, Tarakji KG; WRAP-IT Investigators. Impact of Cardiac Implantable Electronic Device Infection: A Clinical and Economic Analysis of the WRAP-IT Trial. Circ Arrhythm Electrophysiol. 2020 May;13(5):e008280. doi: 10.1161/CIRCEP.119.008280. Epub 2020 Apr 12.

    PubMed 32281393

  • Mittal S, Wilkoff BL, Kennergren C, Poole JE, Corey R, Bracke FA, Curnis A, Addo K, Martinez-Arraras J, Issa ZF, Redpath C, Moubarak J, Khelae SK, Boersma LVA, Korantzopoulos P, Krueger J, Lande JD, Morss GM, Seshadri S, Tarakji KG. The World-wide Randomized Antibiotic Envelope Infection Prevention (WRAP-IT) trial: Long-term follow-up. Heart Rhythm. 2020 Jul;17(7):1115-1122. doi: 10.1016/j.hrthm.2020.02.011. Epub 2020 Feb 19.

    PubMed 32087357

  • Tarakji KG, Mittal S, Kennergren C, Corey R, Poole JE, Schloss E, Gallastegui J, Pickett RA, Evonich R, Philippon F, McComb JM, Roark SF, Sorrentino D, Sholevar D, Cronin E, Berman B, Riggio D, Biffi M, Khan H, Silver MT, Collier J, Eldadah Z, Wright DJ, Lande JD, Lexcen DR, Cheng A, Wilkoff BL; WRAP-IT Investigators. Antibacterial Envelope to Prevent Cardiac Implantable Device Infection. N Engl J Med. 2019 May 16;380(20):1895-1905. doi: 10.1056/NEJMoa1901111. Epub 2019 Mar 17.

    PubMed 30883056

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing TYRX™ Absorbable Antibacterial Envelope in people with CIED Related Infection, run by Medtronic Cardiac Rhythm and Heart Failure at 181 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 181 sites in United States, France, Canada, Italy, Spain and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

12 Month Kaplan-Meier Estimate of Major CIED Infection Rate (time frame: Implant to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02277990, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.

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