Tricuspid RegurgitationHERITAGENCT06309524
Assessing the Right Heart Remodeling After Transcatheter Tricuspid Edge-to-edge Repair
An observational study of Tricuspid Regurgitation, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
In the recent years, secondary tricuspid regurgitation (STR) has gained interest due to its high prevalence and impact on outcomes. Transcatheter tricuspid valve replacement or repair represents novel and less invasive alternatives to surgery and has shown early promising results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- Tricuspid transcatheter edge-to-edge repair
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2023to 1 Jan 2025
- 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: Patients with symptomatic tricuspid regurgitation that fulfill Guidelines criteria for transcatheter tricuspid valve repair
Who may be able to join
- Age> 18 years
- Severe STR, amenable to percutaneous treatment with T-TEER
- Acceptance to be part of this study by signing the informed consent
- Good enough acoustic window and ability to cooperate in order to obtain 3D echo data sets of cardiac structures with a minimum temporal resolution of 20 fps
- Availability for clinical, CCT and, echocardiography follow-up visits
Who cannot join
- Pregnancy
- Severe chronic kidney disease (GFR \<30 mL/min)
- Hypersensitivity reactions to contrast media
- Cardiovascular implantable electronic device-related (CIED) tricuspid regurgitation.
- Bad acoustic window with inadequate echocardiographic images.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano
Milan, Lombardy, 20149
Michele Tomaselli, +3902619112992, michetomaselli@gmail.com
About this study
Official title: Valutazione Del Rimodellamento Delle Camere Destre Dopo Trattamento Transcatetere Edge-to-edge Dell'Insufficienza Tricuspidale Severa
In the recent years, secondary tricuspid regurgitation (STR) has gained interest due to its high prevalence and impact on outcomes. Transcatheter tricuspid valve replacement or repair represents novel and less invasive alternatives to surgery and has shown early promising results. Treatment options mimic surgical techniques such as leaflet approximation, direct annuloplasty, and heterotopic caval valve implantation, as well as not yet commercially available transcatheter TV replacement systems using orthotopic valve implantation. (5) Among leaflet approximation techniques, the Tricuspid transcatheter edge-to-edge repair (T-TEER) using the TriClip™ (Abbott Vascular, Santa Clara, CA, USA) or leaflet approximation with the PASCAL systems (Edwards Lifesciences, Irvine, CA, USA) are approved in Europe for minimally invasive TV repair.The purposes of the present study are: i. to use 3DE and CCT to evaluate the effect of T-TEER on the geometry and function of the right heart chambers in patients with STR; ii. to identify the predictors of procedural success potentially related to features of both right chambers geometry and TR jet; iii. to compare the accuracy of 3DE assessment of the right ventricle, the right atrium, and the tricuspid annulus, with the same parameters obtained by CCT, in the setting of T-TEER; and iv. to assess patients' outcome.
- Conditions
- Tricuspid Regurgitation
- Being tested
- Tricuspid transcatheter edge-to-edge repair
- 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.
Tricuspid transcatheter edge-to-edge repairDevice
Transcatheter tricuspid leaflets approximation
What is being measured
The primary outcome is the main question the study is designed to answer.
Inverse remodeling of right heart chambers
Change in inverse remodeling of right heart chambers at 6 months after intervention
Measured: At baseline and at 6 months after intervention
Heart failure hospitalization
Incidence of heart failure hospitalization during 6 months after intervention
Measured: During 6 months after intervention
Death
Incidence of death during 6 months after intervention
Measured: During 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start15 Feb 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309524
- Sponsor's protocol ID
- 09C332
- Acronym
- HERITAGE
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valutazione Del Rimodellamento Delle Camere Destre Dopo Trattamento Transcatetere Edge-to-edge Dell'Insufficienza Tricuspidale Severa
- ClinicalTrials.gov ID
- NCT06309524
- Acronym / sponsor ID
- HERITAGE / 09C332
- Conditions
- Tricuspid Regurgitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 13 Mar 2024 (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.
In the recent years, secondary tricuspid regurgitation (STR) has gained interest due to its high prevalence and impact on outcomes. Transcatheter tricuspid valve replacement or repair represents novel and less invasive alternatives to surgery and has shown early promising results. Treatment options mimic surgical techniques such as leaflet approximation, direct annuloplasty, and heterotopic caval valve implantation, as well as not yet commercially available transcatheter TV replacement systems using orthotopic valve implantation. (5) Among leaflet approximation techniques, the Tricuspid transcatheter edge-to-edge repair (T-TEER) using the TriClip™ (Abbott Vascular, Santa Clara, CA, USA) or leaflet approximation with the PASCAL systems (Edwards Lifesciences, Irvine, CA, USA) are approved in Europe for minimally invasive TV repair.The purposes of the present study are: i. to use 3DE and CCT to evaluate the effect of T-TEER on the geometry and function of the right heart chambers in patients with STR; ii. to identify the predictors of procedural success potentially related to features of both right chambers geometry and TR jet; iii. to compare the accuracy of 3DE assessment of the right ventricle, the right atrium, and the tricuspid annulus, with the same parameters obtained by CCT, in the setting of T-TEER; and iv. to assess patients' outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic tricuspid regurgitation that fulfill Guidelines criteria for transcatheter tricuspid valve repair
Key inclusion criteria (5 listed)
- Age> 18 years
- Severe STR, amenable to percutaneous treatment with T-TEER
- Acceptance to be part of this study by signing the informed consent
- Good enough acoustic window and ability to cooperate in order to obtain 3D echo data sets of cardiac structures with a minimum temporal resolution of 20 fps
- Availability for clinical, CCT and, echocardiography follow-up visits
Key exclusion criteria (5 listed)
- Pregnancy
- Severe chronic kidney disease (GFR \<30 mL/min)
- Hypersensitivity reactions to contrast media
- Cardiovascular implantable electronic device-related (CIED) tricuspid regurgitation.
- Bad acoustic window with inadequate echocardiographic images.
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 |
|---|---|---|
| Tricuspid transcatheter edge-to-edge repairTranscatheter tricuspid leaflets approximation | Device | – |
Primary outcome
Inverse remodeling of right heart chambers
Time frame: At baseline and at 6 months after intervention
Change in inverse remodeling of right heart chambers at 6 months after intervention
Heart failure hospitalization
Time frame: During 6 months after intervention
Incidence of heart failure hospitalization during 6 months after intervention
Death
Time frame: During 6 months after intervention
Incidence of death during 6 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
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Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
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Recruiting
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
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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.
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 Regurgitation, run by Istituto Auxologico Italiano 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 5 inclusion and 5 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 13 Mar 2024. 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 Luca Grappiolo (+390261911 ext. 2894, luca.grappiolo@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inverse remodeling of right heart chambers (time frame: At baseline and at 6 months after intervention). The study lists 3 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 13 Mar 2024.