Mitral Valve RegurgitationOBSERV-MITRANCT04577248
The Prospecive OBSERVational Munich Interventional MITRAl-Valve Registry
An observational study of Mitral Valve Regurgitation and Mitral Valve Stenosis, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
Prospective, single-center observational registry including all consecutive patients treated with transcatheter mitral or tricuspid valve therapy at the Deutsches Herzzentrum München, Germany. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Mitral Valve Regurgitation, Mitral Valve Stenosis, Tricuspid Valve Regurgitation
- What is being tested?
- edge-to-edge valve repair
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- 1 siteGermany
- Study dates
- 15 Sep 2020to 1 Jan 2031
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All-comers patient population treated with transcatheter mitral or tricuspid valve therapy
Who may be able to join
- Age above 18 years and consentable
- Mitral Valve Regurgitation, Mitral Valve Stenosis, Tricuspid Valve Regurgitation, Tricuspid Stenosis
- Transcatheter mitral or tricuspid valve therapy considered best option by heart-team decision
- Written informed consent
Who cannot join
- Patient's inability to fully cooperate with the protocol
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
Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München
Munich, Bavaria, D80636
Patrick Mayr, MD
About this study
Prospective, single-center observational registry including all consecutive patients treated with transcatheter mitral or tricuspid valve therapy at the Deutsches Herzzentrum München, Germany.
Read the detailed description
Long-term mortality after transcatheter mitral or tricuspid valve therapy
- Being tested
- edge-to-edge valve repair
- Medical subject headings
- Mitral Valve Insufficiency, Mitral Valve Stenosis, Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
edge-to-edge valve repairDevice
edge-to-edge valve repair
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term mortality
Long-term mortality
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start15 Sep 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve 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
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Mayr, MD, Study chair, Dept. of Anesthesiology, Deutsches Herzzentrum MünchenMichael Joner, Prof, Study chair, Dept. of Cardiology, Deutsches Herzzentrum MünchenTobias Rheude, MD, Principal investigator, Dept. of Cardiology, Deutsches Herzzentrum MünchenCostanza Pellegrini, MD, Principal investigator, Dept. of Cardiology, Deutsches Herzzentrum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577248
- Sponsor's protocol ID
- GE DHM-AN-EHK-2020/09
- Acronym
- OBSERV-MITRA
- Status last verified
- Oct 2020
- First submitted
- 1 Oct 2020
- Last updated
- 8 Oct 2020
- Results posted
- 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 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospecive OBSERVational Munich Interventional MITRAl-Valve Registry
- ClinicalTrials.gov ID
- NCT04577248
- Acronym / sponsor ID
- OBSERV-MITRA / GE DHM-AN-EHK-2020/09
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 6 Oct 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.
Prospective, single-center observational registry including all consecutive patients treated with transcatheter mitral or tricuspid valve therapy at the Deutsches Herzzentrum München, Germany.
Detailed description
Long-term mortality after transcatheter mitral or tricuspid valve therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All-comers patient population treated with transcatheter mitral or tricuspid valve therapy
Key inclusion criteria (4 listed)
- Age above 18 years and consentable
- Mitral Valve Regurgitation, Mitral Valve Stenosis, Tricuspid Valve Regurgitation, Tricuspid Stenosis
- Transcatheter mitral or tricuspid valve therapy considered best option by heart-team decision
- Written informed consent
Key exclusion criteria (1 listed)
- Patient's inability to fully cooperate with the protocol
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 |
|---|---|---|
| edge-to-edge valve repairedge-to-edge valve repair | Device | – |
Primary outcome
Long-term mortality
Time frame: 5 years
Long-term mortality
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 8 Oct 2020.
- 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.
Patrick Mayr, MD study chair
Dept. of Anesthesiology, Deutsches Herzzentrum München
Michael Joner, Prof study chair
Dept. of Cardiology, Deutsches Herzzentrum München
Tobias Rheude, MD principal investigator
Dept. of Cardiology, Deutsches Herzzentrum München
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 Mitral Valve Regurgitation and Mitral Valve Stenosis, run by Deutsches Herzzentrum Muenchen 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 4 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 8 Oct 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 Patrick Mayr, MD (+498912180, mayrp@dhm.mhn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term mortality (time frame: 5 years). 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 8 Oct 2020.