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Tauropace to Prevent Cardiac Implantable Device Infections in Heart Failure Patients

Italy500 participantsStarted 2022-06-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Major CIED infections occurring within Twelve months after index procedure

Timeframe: 12 months

Trial details

NCT IDNCT05103267

SponsorFederico II University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-06-06

Contact for this trial

Antonio Rapacciuolo, MD, PhD

+393470660290 antonio.rapacciuolo@unina.it

View on ClinicalTrials.gov More Infection Cardiac trials