Infection CardiacTRICE-HFNCT05103267
Tauropace to Prevent Cardiac Implantable Device Infections in Heart Failure Patients
An observational study of Infection Cardiac and Heart Failure, run by Federico II University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection Cardiac, Heart Failure, Cardiac Implantable Electronic Device Infections
- What is being tested?
- Tauropace
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 6 Jun 2022to 6 Jun 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart failure patients
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Prof Antonio Rapacciuolo,MD, PhD
Naples, 80128
Antonio Rapacciuolo, +393470660290, antonio.rapacciuolo@unina.it
About this study
Official title: Tauropace Reduces Infection After Cardiac Electronic Implantable Device Implantation in Heart Failure Patients
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.
Read the 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.
- Conditions
- Infection Cardiac, Heart Failure, Cardiac Implantable Electronic Device Infections, High Risk
- Being tested
- Tauropace
- Keywords
- cardiac implantable electronic device infection
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TauropaceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Tauropace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
Adverse events after cardiac implantable electronic device implantation
Major mechanical complication and major and/or minor CIED infection rate throughout the duration of the follow-up.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start6 Jun 2022
- Primary completion6 Jun 2023 (estimated)
- Study completion6 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection CardiacStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Rapacciuolo, Federico II University
- Investigators
- Antonio Rapacciuolo, MD, PhD, Principal investigator, Federico II, Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103267
- Sponsor's protocol ID
- 01102101
- Acronym
- TRICE-HF
- Status last verified
- Nov 2022
- First submitted
- 21 Oct 2021
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are planning how to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tauropace Reduces Infection After Cardiac Electronic Implantable Device Implantation in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT05103267
- Acronym / sponsor ID
- TRICE-HF / 01102101
- Conditions
- Infection Cardiac, Heart Failure, Cardiac Implantable Electronic Device Infections, High Risk
- Keywords
- cardiac implantable electronic device infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 6 Jun 2023 (estimated)
- Study completion
- 6 Jun 2024 (estimated)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tauropace in high risk participants | – | Device: TauropaceTauroPace™ 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure patients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TauropaceTauroPace™ 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. | Device | Tauropace in high risk participants |
Primary outcome
Major CIED infections occurring within Twelve months after index procedure
Time frame: 12 months
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.
1 secondary outcome
Adverse events after cardiac implantable electronic device implantation
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: Undecided. We are planning how to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Rapacciuolo, MD, PhD principal investigator
Federico II, Naples
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection Cardiac and Heart Failure, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Rapacciuolo, MD, PhD (+393470660290, antonio.rapacciuolo@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major CIED infections occurring within Twelve months after index procedure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.