Tricuspid RegurgitationNCT04570163
Berlin Registry of Right Heart Interventions
An observational study of Tricuspid Regurgitation and Pulmonary Regurgitation, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The present study evaluates patients after interventional therapy of valvular diseases of the right heart. Follow-up examinations include medical history taking, laboratory measurements and an echo. The aim is to assess the different interventional therapies and their impact on patient's outcome. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Tricuspid Regurgitation, Pulmonary Regurgitation
- What is being tested?
- Interventional therapy mainly of tricuspid regurgitation (TriClip, Cardioband)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 16 Jun 2020to 31 Dec 2035
- How long will I take part?
- 24 Months
- 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 120 years
- All sexes
- Adult, Older adult
Study population: Patients after interventional therapy of valvular diseases of the right heart (such as "cardioband" and "edge-to-edge" techniques of the tricuspid valve) performed in Berlin/ Brandenburg (primarily at the Charité, Universitätsmedizin Berlin).
Who may be able to join
- Patients with planned or recent valve interventions of the right heart (tricuspid regurgitation/ stenosis, pulmonary regurgitation/ stenosis)
- >18 years
- Written, documented consent
Who cannot join
- Patients in care or unable to consent
- Patients who are unable to comply with follow-up examinations
- Patients who are detained in an institution
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
Charité - Universitätsmedizin Berlin
Berlin, 10117
Henryk Dreger, Prof. Dr. med., +49 (0) 30 450 61 34 96, henryk.dreger@charite.de
About this study
The present study evaluates patients after interventional therapy of valvular diseases of the right heart. Follow-up examinations include medical history taking, laboratory measurements and an echo. The aim is to assess the different interventional therapies and their impact on patient's outcome.
Read the detailed description
The subject of the study is to register interventional therapies of right heart diseases (such as "cardioband" and "edge-to-edge" techniques of the tricuspid valve) performed in Berlin/ Brandenburg (primarily at the Charité, Universitätsmedizin Berlin). Based on the development and the increasing use of interventional therapies in tricuspid and pulmonary valve diseases, the impact on the patients' symptoms and life expectancy after interventions will be investigated. The aim is to identify patient subgroups that benefit the most.
Primary endpoints: Total mortality, cardiovascular mortality, heart failure hospitalization.
Secondary endpoints: NYHA class, NTproBNP, liver and kidney function (laboratory measurements), valve function, cardiac function, and cardiac morphology.
- Conditions
- Tricuspid Regurgitation, Pulmonary Regurgitation
- Being tested
- Interventional therapy mainly of tricuspid regurgitation (TriClip, Cardioband)
- Medical subject headings
- Tricuspid Valve Insufficiency, Pulmonary Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional therapy mainly of tricuspid regurgitation (TriClip, Cardioband)Device
Catheter-based therapy of valve diseases of the right heart with various devices (e. g. TriClip, Cardioband).
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall mortality
Number of deceased participants after 2 months after intervention
Measured: 2 months after intervention
Cardiovascular mortality
Number of deceased participants after 2 months after intervention (cardiovascular cause of mortality)
Measured: 2 months after intervention
Unscheduled hospitalization for heart failure progression
Number of participants with unscheduled hospitalization for heart failure progression after 2 months after intervention
Measured: 2 months after intervention
Secondary outcomes (7)
NYHA class
New York Heart Association (NYHA) class (to rate dyspnea in heart failure patients)
Measured: 2 months after intervention
NTproBNP
Laboratory measurement of NTproBNP 2 months after intervention
Measured: 2 months after intervention
valve function
Echocardiographic quantification of valve function (proximal isovelocity surface area [PISA] method, effective regurgitant orifice [ERO], vena contracta [VC]) after 2 months after intervention
Measured: 2 months after intervention
liver function
Laboratory measurement of bilirubin 2 months after intervention
Measured: 2 months after intervention
kidney function
Laboratory measurement of creatinine 2 months after intervention
Measured: 2 months after intervention
cardiac function
Echocardiographic measurement of cardiac function (left ventricular ejection fraction, tricuspid anular plane systolic excursion) after 2 months after intervention
Measured: 2 months after intervention
cardiac morphology
Echocardiographic measurement of cardiac morphology (right ventricular and right atrial diameter) after 2 months after intervention
Measured: 2 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 posted30 Sep 2020
- Study start16 Jun 2020
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (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 Charite University, Berlin, GermanyThe 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
- 200 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Henryk Dreger, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570163
- Sponsor's protocol ID
- EA1/043/20
- Status last verified
- Mar 2026
- First submitted
- 20 Sep 2020
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: As part of the expected publications, it is planned to provide data of the study participants and more detailed information on inclusion and exclusion criteria (study protocol).
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Berlin Registry of Right Heart Interventions
- ClinicalTrials.gov ID
- NCT04570163
- Acronym / sponsor ID
- EA1/043/20
- Conditions
- Tricuspid Regurgitation, Pulmonary Regurgitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 30 Sep 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.
The present study evaluates patients after interventional therapy of valvular diseases of the right heart. Follow-up examinations include medical history taking, laboratory measurements and an echo. The aim is to assess the different interventional therapies and their impact on patient's outcome.
Detailed description
The subject of the study is to register interventional therapies of right heart diseases (such as "cardioband" and "edge-to-edge" techniques of the tricuspid valve) performed in Berlin/ Brandenburg (primarily at the Charité, Universitätsmedizin Berlin). Based on the development and the increasing use of interventional therapies in tricuspid and pulmonary valve diseases, the impact on the patients' symptoms and life expectancy after interventions will be investigated. The aim is to identify patient subgroups that benefit the most.
Primary endpoints: Total mortality, cardiovascular mortality, heart failure hospitalization.
Secondary endpoints: NYHA class, NTproBNP, liver and kidney function (laboratory measurements), valve function, cardiac function, and cardiac morphology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients after interventional therapy of valvular diseases of the right heart (such as "cardioband" and "edge-to-edge" techniques of the tricuspid valve) performed in Berlin/ Brandenburg (primarily at the Charité, Universitätsmedizin Berlin).
Key inclusion criteria (3 listed)
- Patients with planned or recent valve interventions of the right heart (tricuspid regurgitation/ stenosis, pulmonary regurgitation/ stenosis)
- >18 years
- Written, documented consent
Key exclusion criteria (3 listed)
- Patients in care or unable to consent
- Patients who are unable to comply with follow-up examinations
- Patients who are detained in an institution
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 |
|---|---|---|
| Interventional therapy mainly of tricuspid regurgitation (TriClip, Cardioband)Catheter-based therapy of valve diseases of the right heart with various devices (e. g. TriClip, Cardioband). | Device | – |
Primary outcome
Overall mortality
Time frame: 2 months after intervention
Number of deceased participants after 2 months after intervention
Cardiovascular mortality
Time frame: 2 months after intervention
Number of deceased participants after 2 months after intervention (cardiovascular cause of mortality)
Unscheduled hospitalization for heart failure progression
Time frame: 2 months after intervention
Number of participants with unscheduled hospitalization for heart failure progression after 2 months after intervention
7 secondary outcomes
NYHA class
Time frame: 2 months after intervention
NTproBNP
Time frame: 2 months after intervention
valve function
Time frame: 2 months after intervention
liver function
Time frame: 2 months after intervention
kidney function
Time frame: 2 months after intervention
cardiac function
Time frame: 2 months after intervention
cardiac morphology
Time frame: 2 months after intervention
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 19 Mar 2026.
- Individual participant dataSharing planned: Yes. As part of the expected publications, it is planned to provide data of the study participants and more detailed information on inclusion and exclusion criteria (study protocol).
Related trials for Tricuspid Regurgitation
RecruitingObservational study
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
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Tricuspid Regurgitation, Tricuspid Regurgitation Functional
Recruiting
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
Aortic Stenosis, Mitral Regurgitation
Recruiting
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation
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 Pulmonary Regurgitation, run by Charite University, Berlin, Germany 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 3 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 19 Mar 2026. 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 Henryk Dreger, Prof. Dr. med. (+4930450613496, henryk.dreger@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall mortality (time frame: 2 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 19 Mar 2026.