Tricuspid Valve InsufficiencyNCT04522154
Transcatheter Tricuspid Valve Interventions and Right Ventricular Function: Evaluation with Magnetic Resonance Imaging
A study testing Magnet resonance imaging in people with Tricuspid Valve Insufficiency, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
Trial summary
There is an urgent need for transcatheter tricuspid interventions, as pharmaceutical therapy becomes ineffective in advanced disease stages and surgery remains associated with high mortality rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Valve Insufficiency
- What is being tested?
- Magnet resonance imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2020to 9 Mar 2025
- Phase
- Interventional
- 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
Who may be able to join
- Patients with severe tricuspid regurgitation undergoing transcatheter tricuspid intervention.
Who cannot join
- Patient with Incompatibility with magnetic resonance imaging or echocardiography
- Another valve disorder that requires treatment
- Severe precapillary pulmonary hypertension
- Unstable angina or percutaneous coronary intervention within the last 30 days
- Previous pacemaker/defibrillator implantation with intracardiac leads
- Patients with cardiac cachexia or a life expectancy less then 12 months
- Allergies to the material used.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Herz- und Diabeteszentrum, NRW
Bad Oeynhausen, North Rhine-Westphalia, 32545
About this study
There is an urgent need for transcatheter tricuspid interventions, as pharmaceutical therapy becomes ineffective in advanced disease stages and surgery remains associated with high mortality rates. Despite the promising results, in some patients, although good procedural results were achieved, no clinical improvements were measured. Right ventricular dysfunction is suspected to be the cause of the failed therapeutic strategy. Therefore this study aims to analyze right ventricular function with magnet resonance imaging before and 3-months after the procedure in order to gain insight into the prevalence and dynamics of right ventricular dysfunction in severe tricuspid regurgitation and to identify possible predictors for treatment failure.
- Conditions
- Tricuspid Valve Insufficiency
- Being tested
- Magnet resonance imaging
- 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.
Magnet resonance imagingDiagnostic test
Patients will receive a cardiac magnet resonance tomography before and 3-month after the procedure
| Study group | Role | What they receive |
|---|---|---|
| MR-TTE | Other | Patient receiving cardiac magnet resonance imaging and echocardiography Receives: Diagnostic Test: Magnet resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of transcatheter tricuspid intervention on tricuspid annular plane systolic excursion resonance tomography and echocardiography
Changes on tricuspid annular plane systolic excursion in magnet resonance tomography and echocardiography after of transcatheter tricuspid intervention
Measured: 3 month
Influence of transcatheter tricuspid intervention on right ventricular basal diameter excursion in resonance tomography and echocardiography
Changes on right ventricular basal diameter in resonance tomography and echocardiography after transcatheter tricuspid intervention
Measured: 3 Month
Influence of transcatheter tricuspid intervention on right ventricular stroke volume resonance tomography and echocardiography
Changes on right ventricular stroke volume in resonance tomography and echocardiography after transcatheter tricuspid intervention
Measured: 3 Month
Influence of transcatheter tricuspid intervention on right ventricular ejection fraction resonance tomography and echocardiography
Changes on right ventricular ejection fraction in resonance tomography and echocardiography after transcatheter tricuspid intervention
Measured: 3 Month
Influence of transcatheter tricuspid intervention on right ventricular global longitudinal strain resonance tomography and echocardiography
Changes on right ventricular global longitudinal in resonance tomography and echocardiography after transcatheter tricuspid intervention
Measured: 3 Month
Influence of transcatheter tricuspid intervention on right ventricular fractional area change resonance tomography and echocardiography
Changes on right ventricular fractional area change in resonance tomography and echocardiography after transcatheter tricuspid intervention
Measured: 3 Month
Influence of transcatheter tricuspid intervention on tricuspid regurgitant fraction resonance tomography and echocardiography
Changes on tricuspid regurgitant fraction in resonance tomography and echocardiography after transcatheter tricuspid intervention
Measured: 3 Month
Secondary outcomes (5)
Exercise Testing with 6 min walking test
Changes on walked distance after transcatheter tricuspid intervention
Measured: 3 month
rehospitalization rate
Detection of rehospitalization rate after transcatheter tricuspid intervention
Measured: 3 month
Stroke
Detection of stroke rate after transcatheter tricuspid intervention
Measured: 3 month
Death due to cardiovascular complication
Detection of death rate due to cardiovascular complications after transcatheter tricuspid intervention
Measured: 3 month
Influence of transcatheter tricuspid intervention on the cardiopulmonary exercise capacity
Changes on aerobic capacity and endurance using the cardiopulmonary exercise testing (vO2max in milliliter per minute per kilogram)
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start1 Aug 2020
- Primary completion9 Mar 2025
- Study completion9 Mar 2025
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Gerçek, Heart and Diabetes Center North-Rhine Westfalia
- Investigators
- Muhammed Gercek, Dr. med., Principal investigator, Assistant physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522154
- Sponsor's protocol ID
- HDZ-KA_017_MG
- Status last verified
- Jan 2024
- First submitted
- 18 Aug 2020
- Last updated
- 12 Mar 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 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Tricuspid Valve Interventions and Right Ventricular Function: Evaluation with Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT04522154
- Acronym / sponsor ID
- HDZ-KA_017_MG
- Conditions
- Tricuspid Valve Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Heart and Diabetes Center North-Rhine WestfaliaUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 9 Mar 2025 (actual)
- Study completion
- 9 Mar 2025 (actual)
- First posted
- 21 Aug 2020 (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.
There is an urgent need for transcatheter tricuspid interventions, as pharmaceutical therapy becomes ineffective in advanced disease stages and surgery remains associated with high mortality rates. Despite the promising results, in some patients, although good procedural results were achieved, no clinical improvements were measured. Right ventricular dysfunction is suspected to be the cause of the failed therapeutic strategy. Therefore this study aims to analyze right ventricular function with magnet resonance imaging before and 3-months after the procedure in order to gain insight into the prevalence and dynamics of right ventricular dysfunction in severe tricuspid regurgitation and to identify possible predictors for treatment failure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR-TTE | Other | Diagnostic Test: Magnet resonance imagingPatient receiving cardiac magnet resonance imaging and echocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with severe tricuspid regurgitation undergoing transcatheter tricuspid intervention.
Key exclusion criteria (7 listed)
- Patient with Incompatibility with magnetic resonance imaging or echocardiography
- Another valve disorder that requires treatment
- Severe precapillary pulmonary hypertension
- Unstable angina or percutaneous coronary intervention within the last 30 days
- Previous pacemaker/defibrillator implantation with intracardiac leads
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 |
|---|---|---|
| Magnet resonance imagingPatients will receive a cardiac magnet resonance tomography before and 3-month after the procedure | Diagnostic test | MR-TTE |
Primary outcome
Influence of transcatheter tricuspid intervention on tricuspid annular plane systolic excursion resonance tomography and echocardiography
Time frame: 3 month
Changes on tricuspid annular plane systolic excursion in magnet resonance tomography and echocardiography after of transcatheter tricuspid intervention
Influence of transcatheter tricuspid intervention on right ventricular basal diameter excursion in resonance tomography and echocardiography
Time frame: 3 Month
Changes on right ventricular basal diameter in resonance tomography and echocardiography after transcatheter tricuspid intervention
Influence of transcatheter tricuspid intervention on right ventricular stroke volume resonance tomography and echocardiography
Time frame: 3 Month
Changes on right ventricular stroke volume in resonance tomography and echocardiography after transcatheter tricuspid intervention
Influence of transcatheter tricuspid intervention on right ventricular ejection fraction resonance tomography and echocardiography
Time frame: 3 Month
Changes on right ventricular ejection fraction in resonance tomography and echocardiography after transcatheter tricuspid intervention
Influence of transcatheter tricuspid intervention on right ventricular global longitudinal strain resonance tomography and echocardiography
Time frame: 3 Month
Changes on right ventricular global longitudinal in resonance tomography and echocardiography after transcatheter tricuspid intervention
Influence of transcatheter tricuspid intervention on right ventricular fractional area change resonance tomography and echocardiography
Time frame: 3 Month
Changes on right ventricular fractional area change in resonance tomography and echocardiography after transcatheter tricuspid intervention
Influence of transcatheter tricuspid intervention on tricuspid regurgitant fraction resonance tomography and echocardiography
Time frame: 3 Month
Changes on tricuspid regurgitant fraction in resonance tomography and echocardiography after transcatheter tricuspid intervention
5 secondary outcomes
Exercise Testing with 6 min walking test
Time frame: 3 month
rehospitalization rate
Time frame: 3 month
Stroke
Time frame: 3 month
Death due to cardiovascular complication
Time frame: 3 month
Influence of transcatheter tricuspid intervention on the cardiopulmonary exercise capacity
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 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. This study is not recruiting at the moment.
Muhammed Gercek, Dr. med. principal investigator
Assistant physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnet resonance imaging in people with Tricuspid Valve Insufficiency, 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 12 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of transcatheter tricuspid intervention on tricuspid annular plane systolic excursion resonance tomography and echocardiography (time frame: 3 month). The study lists 7 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 12 Mar 2025.