Tricuspid RegurgitationNCT04653428
German Registry for Transcatheter Tricuspid Valve Interventions
An observational study of Tricuspid Regurgitation and Tricuspid Valve Insufficiency, run by LMU Klinikum at 1 site in Germany.
Trial summary
Multicentre observational study of patients with severe tricuspid regurgitation and interventional treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Heart Valve
- What is being tested?
- Interventional treatment of tricuspid regurgitation
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2020to 31 Dec 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe symptomatic tricuspid regurgitation, who are not eligible for cardiac surgery due to a high risk of mortality.
Who may be able to join
- Interventional treatment of severe tricuspid regurgitation (isolated or in combination with another interventional treatment) with a CE certified product for tricuspid valve repair
- Informed consent corresponding to criteria of Good Clinical Practice and the decleration of Helsinki as well as to standards of the local ethic commission.
Who cannot join
- No agreement to participation
- Age < 18 years
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
Klinikum der LMU Muenchen
Munich
Jörg Hausleiter
About this study
Multicentre observational study of patients with severe tricuspid regurgitation and interventional treatment.
Read the detailed description
Severe tricuspid regurgitation occurs in around 1.5 % of men and 5.6 % of women and it is associated with significant morbidity and mortality. Current guidelines recommend cardiac surgery, especially in those patients who are undergoing left side valve surgery. Nevertheless many patients are not eligible for surgical tricuspid valve repair due to an high risk of mortality. Therefore interventional devices for treatment of tricuspid regurgitation have been established to offer these patients an alternative treatment option. The aim of this study is to analyse the success and saftey aspects of different interventional repair techniques for severe tricuspid regurgitation. Therefore in this prospectively designed observational study clinical, echocardiographic and laboratory parameters will be collected.
- Being tested
- Interventional treatment of tricuspid regurgitation
- Keywords
- Tricuspid regurgiation, Tricuspid valve insufficiency, Interventional treatment, Heart valve diseases
- Medical subject headings
- Tricuspid Valve Insufficiency, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional treatment of tricuspid regurgitationDevice
Interventional treatment for tricuspid regurgitatin with CE-certified products, e.g. edge-to-edge repair
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death and heart failure hospitalisation
All-cause death and heart failure hospitalisation 1 year after transcatheter tricuspid valve treatment (TTVT)
Measured: 1 year
Secondary outcomes (9)
All-cause death and heart failure hospitalisation (long-term)
Long-term all-cause death and heart failure hospitalisation after transcatheter tricuspid valve treatment (TTVT)
Measured: up to 5 years
All-cause death and heart failure hospitalisation (short-term)
Short-term all-cause death and heart failure hospitalisation after transcatheter tricuspid valve treatment (TTVT)
Measured: 30-90 days
Change of tricuspid regurgitation after transcatheter tricuspid valve treatment (TTVT)
Assessed by echocardiography, tricuspid regurgitation graded on a 4-grade scale.
Measured: up to 5 years
Change of cardiopulmonal symptoms after transcatheter tricuspid valve treatment (TTVT)
Assessment for cardiopulmonal symptoms include edema scaling
Measured: up to 5 years
Change of NYHA classification after transcatheter tricuspid valve treatment (TTVT)
NYHA classification I, II, III or IV
Measured: up to 5 years
Change of 6-minute walking distance test after transcatheter tricuspid valve treatment (TTVT)
Assessed by standardized protocol testing 6-minute walking distance
Measured: up to 5 years
Change of quality of life after transcatheter tricuspid valve treatment (TTVT)
Quality of life is assessed by standardized questionnaires including the Minnesota Living with Heart Failure Questionnaire
Measured: up to 5 years
Change of NT-proBNP after transcatheter tricuspid valve treatment (TTVT)
N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in pg/ml
Measured: up to 5 years
Procedural success after transcatheter tricuspid valve treatment (TTVT)
Procedural success is defined as a reduction of the tricuspid regurgitation to at least grade 2+ achieved by interventional treatment
Measured: At the day of discharge after transcatheter tricuspid valve treatment (TTVT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Oct 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 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
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Diabetes Center North Rhine-Westphalia, Heart Center Leipzig - University Hospital, Mainz University, Universitätsklinikum Köln, University Hospital, Essen
- Responsible party
- Principal investigator, Prof. Dr. med. Jörg Hausleiter, LMU Klinikum
- Investigators
- Jörg Hausleiter, MD, Principal investigator, Klinikum der LMU Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653428
- Sponsor's protocol ID
- D-TRIK
- Status last verified
- Nov 2020
- First submitted
- 17 Nov 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German Registry for Transcatheter Tricuspid Valve Interventions
- ClinicalTrials.gov ID
- NCT04653428
- Acronym / sponsor ID
- D-TRIK
- Keywords
- Tricuspid regurgiation, Tricuspid valve insufficiency, Interventional treatment, Heart valve diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Collaborators
- Heart and Diabetes Center North Rhine-Westphalia, Heart Center Leipzig - University Hospital, Mainz University, Universitätsklinikum Köln, University Hospital, Essen
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 4 Dec 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.
Multicentre observational study of patients with severe tricuspid regurgitation and interventional treatment.
Detailed description
Severe tricuspid regurgitation occurs in around 1.5 % of men and 5.6 % of women and it is associated with significant morbidity and mortality. Current guidelines recommend cardiac surgery, especially in those patients who are undergoing left side valve surgery. Nevertheless many patients are not eligible for surgical tricuspid valve repair due to an high risk of mortality. Therefore interventional devices for treatment of tricuspid regurgitation have been established to offer these patients an alternative treatment option. The aim of this study is to analyse the success and saftey aspects of different interventional repair techniques for severe tricuspid regurgitation. Therefore in this prospectively designed observational study clinical, echocardiographic and laboratory parameters will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe symptomatic tricuspid regurgitation, who are not eligible for cardiac surgery due to a high risk of mortality.
Key inclusion criteria (2 listed)
- Interventional treatment of severe tricuspid regurgitation (isolated or in combination with another interventional treatment) with a CE certified product for tricuspid valve repair
- Informed consent corresponding to criteria of Good Clinical Practice and the decleration of Helsinki as well as to standards of the local ethic commission.
Key exclusion criteria (2 listed)
- No agreement to participation
- Age < 18 years
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 treatment of tricuspid regurgitationInterventional treatment for tricuspid regurgitatin with CE-certified products, e.g. edge-to-edge repair | Device | – |
Primary outcome
All-cause death and heart failure hospitalisation
Time frame: 1 year
All-cause death and heart failure hospitalisation 1 year after transcatheter tricuspid valve treatment (TTVT)
9 secondary outcomes
All-cause death and heart failure hospitalisation (long-term)
Time frame: up to 5 years
All-cause death and heart failure hospitalisation (short-term)
Time frame: 30-90 days
Change of tricuspid regurgitation after transcatheter tricuspid valve treatment (TTVT)
Time frame: up to 5 years
Change of cardiopulmonal symptoms after transcatheter tricuspid valve treatment (TTVT)
Time frame: up to 5 years
Change of NYHA classification after transcatheter tricuspid valve treatment (TTVT)
Time frame: up to 5 years
Change of 6-minute walking distance test after transcatheter tricuspid valve treatment (TTVT)
Time frame: up to 5 years
Change of quality of life after transcatheter tricuspid valve treatment (TTVT)
Time frame: up to 5 years
Change of NT-proBNP after transcatheter tricuspid valve treatment (TTVT)
Time frame: up to 5 years
Procedural success after transcatheter tricuspid valve treatment (TTVT)
Time frame: At the day of discharge after transcatheter tricuspid valve treatment (TTVT)
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 4 Dec 2020.
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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.
Jörg Hausleiter, MD principal investigator
Klinikum der LMU Muenchen
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 Tricuspid Valve Insufficiency, run by LMU Klinikum 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 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 4 Dec 2020. 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 Jörg Hausleiter, MD (+49 89 4400 72361, joerg.hausleiter@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause death and heart failure hospitalisation (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 4 Dec 2020.