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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 is a Phase 4 study that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 7,075 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02277990
The ClinicalTrials.gov registry entry for NCT02277990 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 7,075 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiac Rhythm and Heart Failure, which has 115 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TYRX™ Absorbable Antibacterial Envelope is the first listed.
NCT02277990 reports 0 study locations.
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.
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