Tauropace to Prevent Cardiac Implantable Device Infections in Heart Failure Patients

NCT05103267 | Unknown

• 1 other identifier: 01102101
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cardiac implantable electronic device infection

Outcome Measures

Primary Outcomes (1)

• Major CIED infections occurring within Twelve months after index procedure

  The primary study objective is to evaluate the rate of major CIED infections through 12-months post-procedure in high-risk patients. Major CIED infection will be defined as a device infection involving any part of the anatomy other than the incision or subcutaneous tissue, which was opened or manipulated during the CIED implantation operation, or as endocarditis defined according to the modified Duke Criteria, that resulted in CIED system removal, an invasive CIED procedure (e.g., pocket revision without removal), treatment with long-term antibiotic therapy (if the patient was not a candidate for system removal) with infection recurrence after discontinuation of antibiotic therapy, or death. CIED infections that will not meet one or more of the criteria for major infection will be classified as minor CIED infections.

  12 months

Secondary Outcomes (1)

• Adverse events after cardiac implantable electronic device implantation

  12 months

Study Arms (1)

Tauropace in high risk participants

TauroPace™ is a CE marked (certified) medical device defined as a "Disinfecting Solution to Eradicate Airborne Microbial Contamination on the Surface of Cardiac Impiantable Electronic Devices (CIED)". TauroPace™ is to eradicate environmental microbial contamination on the surface of any CIED during implantation or revision procedure. TauroPace™ is intended to be used during CIED surgery procedure in any adult participant at high risk of CIED infections

Device: Tauropace

Interventions

Tauropace DEVICE

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.

Tauropace in high risk participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Heart failure patients

You may qualify if:

• Patient is at least 18 years of age, willing to sign and date the study PIC form and is planned to undergo at least one of the following:
• Patient suffering from heart failure (FE\<35%) undergoing de novo single or dual-chamber ICD or CRT-D system implant according to the most recent European Society of Cardiology guidelines
• Patient suffering from heart failure (FE\<35%) with a pre-existing CIED and planned to undergo ICD or CRT-D replacement or upgrading.
• Antibiotic prophylaxis before procedure, surgical preparation with alcoholic chlorhexidine or povidone-iodine, measures to avoid pocket haematoma (avoid heparin bridging, discontinue antiplatelets if possible excluding cardioaspirin) according to current guidelines.

You may not qualify if:

• Life expectancy of \< 12 months or planned to undergo heart transplantation within 6 months.
• Prior history of CIED infection, including endocarditis, in the past 12 months.
• Clinical or laboratory sign or symptoms of active infection
• Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within 7 days prior to device procedure

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Prof Antonio Rapacciuolo,MD, PhD

Naples, 80128, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Antonio Rapacciuolo, MD, PhD

  Federico II, Naples

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Rapacciuolo, MD, PhD

CONTACT

+393470660290; antonio.rapacciuolo@unina.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 2, 2021
• Study Start: June 6, 2022
• Primary Completion: June 6, 2023
• Study Completion: June 6, 2024
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

IT (1)