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NCT02277990 · ClinicalTrials.gov registry record · Phase 4
World-wide Randomized Antibiotic Envelope Infection Prevention Trial
A Phase 4 study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- Phase 4
- Development phase
- 7,075
- Enrollment target
NCT02277990: Completed Phase 4 study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT02277990 is a Phase 4 study that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 7,075 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (1266% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02277990, a Phase 4 study, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 7,075 participants
- Enrollment target
Study 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. 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.
Primary Outcome
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
Interventions
- DEVICE TYRX™ Absorbable Antibacterial Envelope
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7,075 participants |
| Start Date | 2015-01 |
| Est. Completion | 2018-09 |
| Phase | Phase 4 |
What the finished NCT02277990 record still lists
NCT02277990 is an interventional study that assigns participants to a tested intervention. Its 7,075 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (1266% higher).
The record links to 0 conditions, and to 1 intervention - of which TYRX™ Absorbable Antibacterial Envelope is the first listed.
NCT02277990 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02277990 about?
NCT02277990 is a clinical study titled "World-wide Randomized 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 I...
What is the current status of trial NCT02277990?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 7,075 participants. The study started on 2015-01. Estimated completion is 2018-09.
What interventions are being tested in trial NCT02277990?
The interventions under investigation include: TYRX™ Absorbable Antibacterial Envelope (DEVICE).
Who is sponsoring clinical trial NCT02277990?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02277990's enrollment target sits among peer trials
7,075 12th of 2000 higher than 1,989 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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