Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-02 @ 10:48 AM
Study NCT ID:
NCT05103267
Status:
UNKNOWN
Last Update Posted:
2022-11-14
First Post:
2021-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tauropace to Prevent Cardiac Implantable Device Infections in Heart Failure Patients
Sponsor:
Federico II University
Organization:
Study Overview
Official Title:
Tauropace Reduces Infection After Cardiac Electronic Implantable Device Implantation in Heart Failure Patients
Status:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRICE-HF
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: