TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD

NCT01043705 | Completed Results DMC

• 1 other identifier: CP-2009-2
• Study Type: observational
• Target: 1,262
• Locations: 1 country
• Sites: 52

Brief Summary

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.

Conditions

Cardiac Implantable Electronic Device Infection

Keywords

Pacemaker infection; Defibrillator infection; ICD infection; CRT infection; Cardiovascular implantable electronic device infection; Infection; Pacemaker, Artificial; Defibrillators

Outcome Measures

Primary Outcomes (2)

• Major CIED Infection

  CIED Major Infections

  12 months

• CIED Mechanical Complication

  All mechanical Complications related to CIED Implant

  12 months

Study Arms (5)

CIED replacement with CRT and TYRX

(Prospective Arm) Patients who have undergone CIED replacement with a CRT and the TYRX Anti-bacterial envelope, with or without lead revision.

CIED replacement with ICD and TYRX

(Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.

CIED replacement with ICD or CRT and TYRX

(Prospective Arm) Patients who have undergone CIED replacement with an ICD or CRT and the TYRX Anti-bacterial envelope, with or without lead revision.

CIED replacement w/ CRT & no TYRX

(Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.

CIED replacement w/ CRT & TYRX vs. Case Match Arm

Patients who have undergone CIED replacement with a CRT and TYRX Anti-bacterial envelope, with or without lead revision/addition. Cohort is TYRX Case, Matched to Retrospective Case-Control Arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone CIED replacement with an ICD or CRT, with or without (CRT retrospective group only) an TYRX Anti-bacterial Envelope, at US medical centers.

You may qualify if:

• Qualifying CIED Implant procedure was replacement with an ICD or CRT and TYRX, with or without lead revision/addition
• Received a complete TYRX Anti-Bacterial Envelope Model# 3122 or #3133 according to the Instructions for Use (IFU)
• Clinically stable to tolerate procedure
• years or older
• Able to return for follow-up care through the 12-month visit, or able to have referring physician provide follow-up data to study site by telephone

You may not qualify if:

• Unable/unwilling to provide informed consent
• Contraindication to receiving the TYRX device, in accordance with the package labeling
• Pregnant or was at risk for becoming pregnant in the 30 day period following the Qualifying TYRX Implant
• Current CIED infection, or the indication for Qualifying CIED Implant was replacement of CIED that was explanted for infection
• Generator replacement required planned lead extraction
• Participating in another clinical study evaluating a drug or device designed to reduce CIED infections
• Life expectancy of less than 6 months
• Expected to receive a heart transplant within 6 months
• With the exception of the elderly in good mental health, all vulnerable subjects as defined by the FDA Office of Human Research Protection or local IRB will be excluded
• Qualifying CIED Implant was replacement with a CRT and TYRX, with or without lead revision/addition
• First un-enrolled patient meeting case-matching criteria in series of patients implanted with a CIED and no TYRX beginning 24 months prior to the date of first TYRX implant at site. If no matching patients in this period, first un-enrolled matching patient implanted with a CIED and no TYRX beginning 24 months prior to the first TYRX implant at site, searching in reverse chronological order
• Had at least one of following by date of enrollment into the study:
• ≥ 12 months follow-up after Qualifying TYRX Implant
• Subsequent TYRX Procedure that required opening the generator pocket or implant incision ≤ 12 months after Qualifying TYRX Implant (e.g. battery change, upgrade, lead revision, explant)
• Death ≤ 12 months after Qualifying CIED Implant

Sponsors & Collaborators

• TYRX, Inc.: lead

Study Sites (52)

Princeton Medical Center

Birmingham, Alabama, 35211, United States

Location

Decatur General Hospital

Decatur, Alabama, 35601, United States

Location

Eliza Coffee Memorial Hospital

Florence, Alabama, 35630, United States

Location

Riverview Regional Hospital

Gadsden, Alabama, 35901, United States

Location

Arizona Heart Hospital

Scottsdate, Arizona, 85251, United States

Location

Community Memorial Hospital

Ventura, California, 93003, United States

Location

Watsonville Community Hospital

Watsonville, California, 95076, United States

Location

Citrus Memorial Hospital

Inverness, Florida, 34452, United States

Location

Osceola Regional Medical Center

Kissimmee, Florida, 34741, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Orlando Regional Hospital

Orlando, Florida, 32806, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

Piedmont Medical Center

Atlanta, Georgia, 30309, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Veteran's Administration Medical Center

Atlanta, Georgia, 30345, United States

Location

Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Trinity Medical Center

Rock Island, Illinois, 61201, United States

Location

St. John's Hospital

Springfield, Illinois, 62769, United States

Location

St. Mary's Medical

Hobart, Indiana, 46342, United States

Location

Community Hospital, Munster

Munster, Indiana, 46321, United States

Location

St. Margaret Mercy

Munster, Indiana, 46321, United States

Location

P and S Surgical Hospital

Monroe, Louisiana, 71201, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University Hospital

Baltimore, Maryland, 21205, United States

Location

Penninsula Regional Medical Center

Salisbury, Maryland, 21804, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02144, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Sparrow Hospital

Lansing, Michigan, 48910, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Gulfport Memorial Hospital

Biloxi, Mississippi, 39532, United States

Location

Keesler Air Force Base Hospital

Biloxi, Mississippi, 39534, United States

Location

Southern Heart Center

Hattiesburg, Mississippi, 39401, United States

Location

Alegent Health

Omaha, Nebraska, 68124, United States

Location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

St. Francis Hospital

Hamilton, New Jersey, 08690, United States

Location

Newark Beth Israel Hospital

Newark, New Jersey, 07112, United States

Location

Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Our Lady of Lourdes Hospital

Sewell, New Jersey, 08080, United States

Location

St. Luke's - Roosevelt Hospital

New York, New York, 10025, United States

Location

Frye Regional Medical Center

Hickory, North Carolina, 28601, United States

Location

Catholic Health Partners

Youngstown, Ohio, 44510, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

Pinnacle Health Harrisburg Hospital

Harrisburg, Pennsylvania, 17110, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

York Hospital

York, Pennsylvania, 17403, United States

Location

Landmark Medical Center

Woonsocket, Rhode Island, 02895, United States

Location

Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States

Location

University of Tenn. Medical Center - Knoxville

Knoxville, Tennessee, 37920, United States

Location

Texas Heart Institute - St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

NE Methodist

San Antonio, Texas, 78258, United States

Location

Aurora Health Care

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (3)

• Sohail MR, Henrikson CA, Braid-Forbes MJ, Forbes KF, Lerner DJ. Comparison of mortality in women versus men with infections involving cardiovascular implantable electronic device. Am J Cardiol. 2013 Nov 1;112(9):1403-9. doi: 10.1016/j.amjcard.2013.06.031. Epub 2013 Aug 22.

  PMID: 23972346 BACKGROUND

• Ballo P, Chiodi L, Zuppiroli A. Cardiac implantable electronic devices: prevention starts from ethics. Arch Intern Med. 2012 Apr 23;172(8):670-1; author reply 671-2. doi: 10.1001/archinternmed.2012.346. No abstract available.

  PMID: 22529239 BACKGROUND

• Henrikson CA, Sohail MR, Acosta H, Johnson EE, Rosenthal L, Pachulski R, Dan D, Paladino W, Khairallah FS, Gleed K, Hanna I, Cheng A, Lexcen DR, Simons GR. Antibacterial Envelope Is Associated With Low Infection Rates After Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Device Replacement: Results of the Citadel and Centurion Studies. JACC Clin Electrophysiol. 2017 Oct;3(10):1158-1167. doi: 10.1016/j.jacep.2017.02.016. Epub 2017 May 31.

  PMID: 29759500 DERIVED

MeSH Terms

Conditions

Infections

Limitations and Caveats

This was a non-randomized study and did not have an active comparator.

Results Point of Contact

• Title: Lynn Landborg, Clinical Research Manager
• Organization: Medtronic plc

lynn.landborg@medtronic.com

763 526 2877

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 7, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: May 1, 2015
• Last Updated: December 24, 2015
• Results First Posted: December 24, 2015

Record last verified: 2015-10

Locations

US (52)