Tricuspid RegurgitationCESAR-TRNCT06951126
CT Prediction for Transcatheter Tricuspid Interventions
An observational study of Tricuspid Regurgitation and Computed Tomography, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
Trial summary
The aim of this study is to enhance the predictability of therapeutic success in transcatheter tricuspid valve intervention (TTVI) for patients with severe tricuspid regurgitation (TR). This will be achieved through automated analyses of pre-interventional computed tomography (CT) scans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation, Computed Tomography
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 19 Jul 2023to 1 Jun 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study includes patients with >moderate tricuspid regurgitation who underwent cardiac computed tomography and transcatheter tricupid valve intervention.
Who may be able to join
- the patient underwent full cycle cardiac computed tomography for analysis of valvular heart disease
- a transcatheter tricuspid valve intervention is performed
- the patient is 18 years or older
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Herz- und Diabeteszentrum
Bad Oeynhausen, North Rhine-Westphalia, 32545
Johannes Kirchner, Dr. med., jkirchner@hdz-nrw.de
About this study
The aim of this study is to enhance the predictability of therapeutic success in transcatheter tricuspid valve intervention (TTVI) for patients with severe tricuspid regurgitation (TR). This will be achieved through automated analyses of pre-interventional computed tomography (CT) scans.
Severe tricuspid regurgitation is associated with poor patient outcomes. In advanced stages, pharmacological therapy becomes ineffective, and surgical intervention carries a high mortality risk. Given this clinical challenge, catheter-based treatment of the tricuspid valve has become a focal point of research.
Read more
One well-established treatment strategy is percutaneous tricuspid valve intervention, which aims to reduce regurgitation either through annuloplasty, leaflet-based edge-to-edge repair or valve replacement. This approach has been shown to significantly decrease the severity of regurgitation, leading to a dramatic reduction in symptom burden and a marked improvement in quality of life.
However, predicting which patients will benefit most from TTVI and determining the optimal technique for each individual remain largely unresolved challenges.
Artificial intelligence (AI)-powered software, such as heart.ai by LARALAB (Munich), enables automated measurement of anatomical structures captured via CT imaging. This technology already allows for rapid and precise assessment of cardiac chambers and the tricuspid annulus throughout the entire cardiac cycle, facilitating a comprehensive three-dimensional evaluation of right heart anatomy.
To refine patient selection and optimize procedural strategies for TR treatment, the researcher work a multi-center collaboration to analyze treatment outcomes and patient response to specific therapeutic approaches.
- Conditions
- Tricuspid Regurgitation, Computed Tomography
- Keywords
- transcatheter tricuspid valve intervention, TTVI, TR, MSCT, Tricuspid regurgitation
- Medical subject headings
- Tricuspid Valve Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Detection of mortality after transcatheter tricuspid intervention
Measured: 1 year
Secondary outcomes (5)
Residual Tricuspid Regurgitation
Grade of residual tricuspid regurgitation after transcatheter tricuspid valve intervention
Measured: At discharge, 30 days and 1 year
rehospitalization rate
Detection of rehospitalization rate after transcatheter tricuspid intervention
Measured: 1 year
reintervention rate
Detection of reintervention rate on the tricuspid valve after transcatheter tricuspid intervention
Measured: 1 year
NYHA Class
Changes on New York Heart Association functional class after transceather tricuspid valve intervention
Measured: 30 days and 1 year
Intraprocedural success
All of the following must be present:
- Absence of intraprocedural mortality or stroke; and
- Successful access, delivery, and retrieval of the device delivery system; and
- Successful deployment and correct positioning of the intended device(s) without requiring implantation of unplanned additional devices; and
- Adequate performance of the transcatheter device. Performance of devices whose purpose is a reduction in TR, should include the absence of tricuspid stenosis, reduction of total tricuspid regurgitation to optimal
- Absence of device-related obstruction of forward flow
- Absence of device-related pulmonary embolism
- Freedom from emergency surgery or reintervention during the first 24 h related to the device or access procedure
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start19 Jul 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2030 (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.
- 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
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, University Hospital Schleswig-Holstein, University of Cologne, Heart Center Leipzig - University Hospital, Charite University, Berlin, Germany, University of Bern, University Medical Center Mainz
- Responsible party
- Principal investigator, Johannes Kirchner, Heart and Diabetes Center North-Rhine Westfalia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951126
- Sponsor's protocol ID
- HDZ-KA CESAR-TR
- Acronym
- CESAR-TR
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 30 Apr 2025
- 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 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Prediction for Transcatheter Tricuspid Interventions
- ClinicalTrials.gov ID
- NCT06951126
- Acronym / sponsor ID
- CESAR-TR / HDZ-KA CESAR-TR
- Conditions
- Tricuspid Regurgitation, Computed Tomography
- Keywords
- transcatheter tricuspid valve intervention, TTVI, TR, MSCT, Tricuspid regurgitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Heart and Diabetes Center North-Rhine WestfaliaUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, University Hospital Schleswig-Holstein, University of Cologne, Heart Center Leipzig - University Hospital, Charite University, Berlin, Germany, University of Bern, University Medical Center Mainz
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 30 Apr 2025 (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 aim of this study is to enhance the predictability of therapeutic success in transcatheter tricuspid valve intervention (TTVI) for patients with severe tricuspid regurgitation (TR). This will be achieved through automated analyses of pre-interventional computed tomography (CT) scans.
Severe tricuspid regurgitation is associated with poor patient outcomes. In advanced stages, pharmacological therapy becomes ineffective, and surgical intervention carries a high mortality risk. Given this clinical challenge, catheter-based treatment of the tricuspid valve has become a focal point of research.
One well-established treatment strategy is percutaneous tricuspid valve intervention, which aims to reduce regurgitation either through annuloplasty, leaflet-based edge-to-edge repair or valve replacement. This approach has been shown to significantly decrease the severity of regurgitation, leading to a dramatic reduction in symptom burden and a marked improvement in quality of life.
However, predicting which patients will benefit most from TTVI and determining the optimal technique for each individual remain largely unresolved challenges.
Artificial intelligence (AI)-powered software, such as heart.ai by LARALAB (Munich), enables automated measurement of anatomical structures captured via CT imaging. This technology already allows for rapid and precise assessment of cardiac chambers and the tricuspid annulus throughout the entire cardiac cycle, facilitating a comprehensive three-dimensional evaluation of right heart anatomy.
To refine patient selection and optimize procedural strategies for TR treatment, the researcher work a multi-center collaboration to analyze treatment outcomes and patient response to specific therapeutic approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study includes patients with >moderate tricuspid regurgitation who underwent cardiac computed tomography and transcatheter tricupid valve intervention.
Key inclusion criteria (3 listed)
- the patient underwent full cycle cardiac computed tomography for analysis of valvular heart disease
- a transcatheter tricuspid valve intervention is performed
- the patient is 18 years or older
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 1 year
Detection of mortality after transcatheter tricuspid intervention
5 secondary outcomes
Residual Tricuspid Regurgitation
Time frame: At discharge, 30 days and 1 year
rehospitalization rate
Time frame: 1 year
reintervention rate
Time frame: 1 year
NYHA Class
Time frame: 30 days and 1 year
Intraprocedural success
Time frame: 30 days
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 30 Apr 2025.
- 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.
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 and Computed Tomography, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
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 3 inclusion and 1 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 30 Apr 2025. 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 Germany. 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 Johannes Kirchner, Dr. med. (0405731971258, jkirchner@hdz-nrw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 1 year). 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 30 Apr 2025.