Tricuspid Valve InsufficiencyTRIC-ITNCT04735003
Transcatheter Interventions for Tricuspid Insufficiency in Italy
An observational study of Tricuspid Valve Insufficiency, run by Marianna Adamo at 1 site in Italy.
Trial summary
This is an observational, multi-center, retrospective and prospective study collecting data about patients undergoing transcatheter tricuspid valve interventions in a real world clinical environment. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Tricuspid Valve Insufficiency
- What is being tested?
- Transcatheter tricuspid valve interventions
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jan 2021to 30 Jan 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with significant tricuspid regurgitation who need transcatheter tricuspid valve intervention.
Who may be able to join
- Patients undergoing transcatheter treatment of tricuspid regurgitation (native valve -with or without previous surgical valve repair - or degenerated bioprosthesis)
- Patients who are willing and capable of providing informed consent, and participating in all follow-ups associated with this clinical investigation.
Who cannot join
- Valve anatomy unsuitable for transcatheter tricuspid valve interventions.
- Subjects who are unable or not willing to complete follow-up visits and examination for the duration of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Paolo Denti contact
Italy1 site, 1 recruiting
- Recruiting
Marianna Adamo
Brescia, Lombardy, 25123
Marianna Adamo, +390303995564, mariannaadamo@hotmail.com
Paolo Denti, paolodenti@hotmail.com
About this study
Official title: TRans-catheter Interventions for triCuspid Valve Insufficiency: the iTalian Multicentre Study
This is an observational, multi-center, retrospective and prospective study collecting data about patients undergoing transcatheter tricuspid valve interventions in a real world clinical environment. The aim is to report clinical characteristics, procedural results and short- and long-term outcomes of patients undergoing transcatheter tricuspid valve interventions in Italian centres.
- Conditions
- Tricuspid Valve Insufficiency
- Being tested
- Transcatheter tricuspid valve interventions
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter tricuspid valve interventionsDevice
Transcatheter repair or replacement to treat tricuspid regurgitation
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death
Measured: 1-year
Cardiovascular death or heart failure hospitalization
Measured: 1-year
Secondary outcomes (9)
Changes in tricuspid regurgitation degree
Measured: 30-day, 1-year and 5-year
Changes in NYHA class
Measured: 30-day, 1-year and 5-year
Changes in right ventricular dimensions and function
Measured: 30-day, 1-year and 5-year
Changes in liver and kidney function
Measured: 30-day, 1-year and 5-year
Changes in medical therapy (i.e. diuretic dose)
Measured: 30-day, 1-year and 5-year
All-cause death
Measured: 30-day
All-cause death
Measured: 5-year
Cardiovascular death or heart failure hospitalization
Measured: 30-day
Cardiovascular death or heart failure hospitalization
Measured: 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start30 Jan 2021 (estimated)
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Valve InsufficiencyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Marianna Adamo
- Sponsor type
- University, hospital or other
- Collaborators
- San Raffaele University Hospital, Italy
- Responsible party
- Sponsor-investigator, Marianna Adamo, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735003
- Sponsor's protocol ID
- 581011977013
- Acronym
- TRIC-IT
- Status last verified
- Jan 2021
- First submitted
- 16 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRans-catheter Interventions for triCuspid Valve Insufficiency: the iTalian Multicentre Study
- ClinicalTrials.gov ID
- NCT04735003
- Acronym / sponsor ID
- TRIC-IT / 581011977013
- Conditions
- Tricuspid Valve Insufficiency
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Marianna AdamoUniversity, hospital or other
- Collaborators
- San Raffaele University Hospital, Italy
- Study start
- 30 Jan 2021 (estimated)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 2 Feb 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.
This is an observational, multi-center, retrospective and prospective study collecting data about patients undergoing transcatheter tricuspid valve interventions in a real world clinical environment. The aim is to report clinical characteristics, procedural results and short- and long-term outcomes of patients undergoing transcatheter tricuspid valve interventions in Italian centres.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with significant tricuspid regurgitation who need transcatheter tricuspid valve intervention.
Key inclusion criteria (2 listed)
- Patients undergoing transcatheter treatment of tricuspid regurgitation (native valve -with or without previous surgical valve repair - or degenerated bioprosthesis)
- Patients who are willing and capable of providing informed consent, and participating in all follow-ups associated with this clinical investigation.
Key exclusion criteria (2 listed)
- Valve anatomy unsuitable for transcatheter tricuspid valve interventions.
- Subjects who are unable or not willing to complete follow-up visits and examination for the duration of the study.
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 |
|---|---|---|
| Transcatheter tricuspid valve interventionsTranscatheter repair or replacement to treat tricuspid regurgitation | Device | – |
Primary outcome
All-cause death
Time frame: 1-year
Cardiovascular death or heart failure hospitalization
Time frame: 1-year
9 secondary outcomes
Changes in tricuspid regurgitation degree
Time frame: 30-day, 1-year and 5-year
Changes in NYHA class
Time frame: 30-day, 1-year and 5-year
Changes in right ventricular dimensions and function
Time frame: 30-day, 1-year and 5-year
Changes in liver and kidney function
Time frame: 30-day, 1-year and 5-year
Changes in medical therapy (i.e. diuretic dose)
Time frame: 30-day, 1-year and 5-year
All-cause death
Time frame: 30-day
All-cause death
Time frame: 5-year
Cardiovascular death or heart failure hospitalization
Time frame: 30-day
Cardiovascular death or heart failure hospitalization
Time frame: 5-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Paolo Denti contact
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 Tricuspid Valve Insufficiency, run by Marianna Adamo 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 2 Feb 2021. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marianna Adamo (+390303995564, mariannaadamo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause death (time frame: 1-year). The study lists 2 primary outcomes in all. 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 2 Feb 2021.