Tauropace to Prevent Cardiac Implantable Device Infections in Heart Failure Patients
NCT05103267 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500
Last updated 2022-11-14
Summary
The main purpose of the study is to evaluate the ability of the Tauropace to reduce major cardiac implantable electronic device (CIED) infections through 12-months post-procedure following CIED in heart failure participants. The secondary endpoint is to prospectively characterize the performance of Tauropace in participants whose CIED system includes a transvenous RV defibrillation lead.
Conditions
- Infection Cardiac
- Heart Failure
- Cardiac Implantable Electronic Device Infections
- High Risk
Interventions
- DEVICE
-
Tauropace
TauroPace™ contains disinfecting substances to eradicate environmental microbial contamination on the surface of cardiac implantable electronic devices (CIEDs). The surface of the CIED is moistened with TauroPace™ during the implantation procedure to create a hostile environment on the surface of the CIED.
Sponsors & Collaborators
-
Federico II University
lead OTHER
Principal Investigators
-
Antonio Rapacciuolo, MD, PhD · Federico II, Naples
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-06
- Primary Completion
- 2023-06-06
- Completion
- 2024-06-06
Countries
- Italy
Study Locations
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