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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
7,075
Alaska Heart Institute
Anchorage, Alaska, United States
Tri-City Cardiology Consultants
Mesa, Arizona, United States
Arizona Arrhythmia Consultants
Scottsdale, Arizona, United States
Chula Vista Cardiac Center
Chula Vista, California, United States
Cardiovascular Consultants Heart Center
Fresno, California, United States
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
Time frame: Implant to 12 months
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
Time frame: Implant to 12 months
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
Time frame: Implant to 12 months
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
Time frame: Throughout study follow-up Kaplan-Meier Estimate is at 36 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
UCSD Medical Center
La Jolla, California, United States
Eisenhower Desert Cardiology Center
Rancho Mirage, California, United States
University of California San Francisco UCSF Medical Center
San Francisco, California, United States
Stanford Hospital & Clinics
Stanford, California, United States
Saint Joseph's Medical Center
Stockton, California, United States
...and 171 more locations