Clinical trial NCT05103267: Tauropace to Prevent Cardiac Implantable Device Infections in Heart Failure Patients
Official title: Tauropace Reduces Infection After Cardiac Electronic Implantable Device Implantation in Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection Cardiac
Heart Failure
Cardiac Implantable Electronic Device Infections
High Risk
Keywords: cardiac implantable electronic device infection
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Heart failure patients

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.

Detailed description: TRICE-HF is a prospective, multi-center, post-market, interventional clinical study. The main purpose of the study is to evaluate the ability of the Tauropace to reduce major CIED infections through 12-months post-procedure following CIED in heart failure patients. The secondary endpoint is to prospectively characterize the performance of Tauropace in subjects whose CIED system includes a transvenous RV defibrillation lead. These features include the lead integrity alert (LIA), lead noise alert (LNA), RV pacing impedance, and high voltage (HV) pacing impedance to detect events that affect a RV lead's pacing, sensing, or defibrillation circuit lead system events (LSE).

The study will be conducted at up to 10 sites in Italy with up to 500 subjects enrolled.

The enrollment period is expected to start in November 2021 and to take approximately 12 months. Participants will be followed for a minimum of 12 months. Therefore, the anticipated study duration is approximately 24 months and subjects may be followed for up to 24 months depending on when they enroll in the study.

This study is a nonrandomized registry; hence no formal control group will be used. In order to compare our follow-up data, the investigators performed an electronic search of the PubMed and Embase, including all RCTs, retrospective or prospective studied that resulted in CIED infection rates.

The investigators excluded all studies that included patients with abdominal device implants.

No restrictions were imposed on the sample size of the studies. Incidence CIED infections rate or Odds Ratio with 95% confidence intervals were presented as a summary statistic, with the use of the random effects model postulated by DerSimonian and Laird.

Meta-regression was performed to assess the relationship between the magnitude of the treatment effect and different predictors. To estimate the CIED infections incidence in subgroups with certain risk factors, the investigators used the percentage of patients with diabetes, chronic renal failure, undergoing replacement/upgrade/revision procedure, and other CIED infections risk factors, as continuous variables. The investigators predicted a percentage of diabetes and Chronic renal failure patients in our population of 20% and 45 % respectively, but will be able to modify the comparison parameters based on the real percentage of risk factors in the enrolled participants.

Statistical analysis was performed using the "meta" package, with "metagen", "metabin" and "metareg" command, in R programming, R version 4.0.2 (2020-06-22). Results were considered statistically significant if the 2-sided P\<0,05.

A 2-sample, 1-sided Fischer Exact test will be used to test the primary efficacy endpoint versus the benchmark rate.

Baseline characteristics will be compared using a Student t test for continuous variables or a Fisher's exact/chi-square test for categorical variables. A Fisher's exact test will be used for sparse data (i.e., np \<5 or nq \<5). CIED infection and mechanical complication data among ICD and CRT subjects will be compared using the chi-square or Fisher's exact tests. A Fisher's exact test will be used for sparse data.

The study may be considered successful at the first analysis in which the primary objective is met.

Eligibility criteria: Inclusion Criteria:

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:

1. 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
2. Patient suffering from heart failure (FE\<35%) with a pre-existing CIED and planned to undergo ICD or CRT-D replacement or upgrading.
3. 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:

1. Life expectancy of \< 12 months or planned to undergo heart transplantation within 6 months.
2. Prior history of CIED infection, including endocarditis, in the past 12 months.
3. Clinical or laboratory sign or symptoms of active infection
4. 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

Primary outcomes:
measure: Major CIED infections occurring within Twelve months after index procedure
timeFrame: 12 months
Secondary outcomes:
measure: Adverse events after cardiac implantable electronic device implantation
timeFrame: 12 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Prof Antonio Rapacciuolo,MD, PhD
Study officials:
affiliation: Federico II, Naples
name: Antonio Rapacciuolo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: