The primary study objective is to compare the rate of major CIED infections through 12-months post-implant between the TYRX envelope group and the control group.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study objective is to compare the rate of major CIED infections
through 12-months post-implant between the TYRX envelope group and the control
group.
Secondary outcome
Secondary objectives
- Confirm that the TYRX envelope does not increase the CIED procedure-related
or system-related complication rate through 12-months post-procedure.
- Compare the major CIED infection rate during the entire follow-up between the
TYRX envelope group and the control group.
- Compare the rate of major and minor CIED infections through 12-months
post-procedure between the TYRX envelope group and the control group.
Ancillary objectives
- Compare all-cause mortality rates between the TYRX envelope group and the
control group
- Evaluate the CIED procedure success rate in the TYRX envelope group and the
control group
• Control: device and leads all implanted
• Treatment: TYRX envelope, device, and leads all implanted
- Summarize the adverse events
- Identify the predictors of CIED infection
- Summarize quality of life
- Evaluate the cost effectiveness of the TYRX envelope
Background summary
Over the last few decades, there has been a growing evidence of the importance
of Cardiac Implantable Electronic Devices (CIEDs) in improving both quality of
life and survival among patients with heart disease.¹ ² This has resulted in
expansion of the indications for CIED implant which is reflected in the most
recent guidelines from the American College of Cardiology / American Heart
Association/Heart Rhythm Society for CIED implantation and its most recent
update.³ 4 In the United States, recent data estimate that in 2011 about
350,000 patients underwent a permanent pacemaker (PPM) implant, and about
210,000 underwent an implantable cardioverter defibrillator (ICD) implant (in
press). With expanding indications for these devices and an increasingly aging
population, more devices are implanted for older patients with more
comorbidities.5 6 This growth of newly implanted CIEDs has led to an increased
recognition and awareness of associated complications, and infection is among
the most important. Growing indications for CIEDs, coupled with an older and
sicker patient population, contributed to significant increase in the rate of
CIED infection cases. These infections are very serious as they are associated
with significant morbidity and mortality and represent a significant financial
burden on an already ailing health care system.
Study objective
The primary study objective is to compare the rate of major CIED infections
through 12-months post-implant between the TYRX envelope group and the control
group.
Study design
The World-wide Randomized Antibiotic EnveloPe Infection PrevenTion Trial
(WRAP-IT) is a randomized, prospective multi-center, single blinded,
post-market, interventional clinical study.
Intervention
The study intervention is the randomization and the placement of the TYRX
envelop with the (planned) CIED (re)placement in the testgroup.
Study burden and risks
The burden and risc related to the study can be divided into 3 categories:
surgery related, CIED implant related and TYRX envelope related.
Since all patient will undergo a CIED implant procedure only the TYRX envelope
burden and risks are applicable for this section. A list of foreseen adverse
events can be found in the protocol Appendix G. A risk-to-benefit analysis can
be found in section 10.3 of the protocol.
Since the study is randomized, these risks are only applicable for the
treatment group. No extra burden or risks are expected for the control group.
Earl Bakkenstraat 10
Heerlen 6422 PJ
NL
Earl Bakkenstraat 10
Heerlen 6422 PJ
NL
Listed location countries
Age
Inclusion criteria
- Patient is at least 18 years old
- Patient is planned to undergo at least one of the following:
a. Patient has existing CIED and is undergoing IPG (including CRT-D), ICD or CRT-D replacement or upgrade with a new Medtronic generator.
i. Subjects planned to have leads added, or extracted and added for upgrades can be enrolled.
OR
b. Patient will undero a de novo Medtronic CRT-D system implant per approved indications
OR
c. Patient has an existing study eligible Medtronic CIED in which the pocket was not accessed within the last 365 days, and is undergoing pocket or lead revision.
Exclusion criteria
- Known allergy to minocyclin or rifampin or their derivates, or any other known contraindications to implantation of the TYRX envelope
- Current therapy with chronic oral immunosuppressive agents or >= 20 mg/day of Prednisone or equivalent.
- Hemodialysis or peritoneal dialysis
- Prior cardiac transplantation or existing ventricular assist device (VAD)
- Require long-term vascular acces for any reason
- Prior history of a CIED infection, other prosthetic device infection, or endovascular infection, including endocarditis, in the past 12 months.
- Physical, clinical, or laboratory signs or symptoms consistent with an active infection (including, but not limited to pneumonia, urinary tract, cellulitis, or bacteremia)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52063.100.15 |