Mitral Valve RegurgitationNCT03104660
Coronary and Structural Interventions Ulm - Transcatheter Mitral Valve Repair (CSI-Ulm-TMVR)
A study testing CE certified mitral valve repair systems in people with Mitral Valve Regurgitation, run by University of Ulm at 1 site in Germany.
Trial summary
To evaluate the long-term results after transcatheter mitral valve repair Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Regurgitation
- What is being tested?
- CE certified mitral valve repair systems
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 1 siteGermany
- Study dates
- 15 Mar 2017to 31 Dec 2018
- 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
- mitral valve regurgitation
- transcatheter mitral valve repair
Who cannot join
- no written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the long-term results after transcatheter mitral valve repair
Read the detailed description
Patients with transcatheter mitral valve repair are followed for 10 years to demonstrate efficacy and safety.
- Conditions
- Mitral Valve Regurgitation
- Being tested
- CE certified mitral valve repair systems
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CE certified mitral valve repair systemsDevice
Patients receive a transcatheter mitral valve repair with CE certified transcatheter mitral repair systems.
| Study group | Role | What they receive |
|---|---|---|
| CE certified mitral valve repair systems | Experimental | CE certified transcatheter mitral valve repair systems Receives: Device: CE certified mitral valve repair systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cerebral and cardiac events
Major adverse cerebral and cardiac events
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start15 Mar 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- CE certified mitral valve repair systems
- Masking
- None (open label)
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jochen Wohrle, University of Ulm
- Investigators
- Jochen Woehrle, MD, Principal investigator, University Hospital Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104660
- Sponsor's protocol ID
- CSI-Ulm-TMVR
- Status last verified
- Apr 2020
- First submitted
- 3 Apr 2017
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seeger J, Markovic S, Kessler M, Rottbauer W, Wohrle J. Apixaban After Percutaneous Edge-to-Edge Mitral Valve Repair in Patients With Maintained Sinus Rhythm. JACC Cardiovasc Interv. 2019 Jan 28;12(2):214-216. doi: 10.1016/j.jcin.2018.11.009. No abstract available.
PubMed 30678801Seeger J, Muller P, Gonska B, Scharnbeck D, Markovic S, Walcher D, Rottbauer W, Wohrle J. Percutaneous Mitral Valve Repair With the MitraClip in Primary Compared With Secondary Mitral Valve Regurgitation Using the Mitral Valve Academic Research Consortium Criteria. J Invasive Cardiol. 2017 Apr;29(4):145-150.
PubMed 28368846
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary and Structural Interventions Ulm - Transcatheter Mitral Valve Repair (CSI-Ulm-TMVR)
- ClinicalTrials.gov ID
- NCT03104660
- Acronym / sponsor ID
- CSI-Ulm-TMVR
- Conditions
- Mitral Valve Regurgitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 7 Apr 2017 (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.
To evaluate the long-term results after transcatheter mitral valve repair
Detailed description
Patients with transcatheter mitral valve repair are followed for 10 years to demonstrate efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- CE certified mitral valve repair systems
| Arm | Type | Receives |
|---|---|---|
| CE certified mitral valve repair systems | Experimental | Device: CE certified mitral valve repair systemsCE certified transcatheter mitral valve repair systems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- mitral valve regurgitation
- transcatheter mitral valve repair
Key exclusion criteria (1 listed)
- no written informed consent
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 |
|---|---|---|
| CE certified mitral valve repair systemsPatients receive a transcatheter mitral valve repair with CE certified transcatheter mitral repair systems. | Device | CE certified mitral valve repair systems |
Primary outcome
Major adverse cerebral and cardiac events
Time frame: 10 years
Major adverse cerebral and cardiac events
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 28 Apr 2020.
- Results publication: PubMed 30678801Seeger J, Markovic S, Kessler M, Rottbauer W, Wohrle J. Apixaban After Percutaneous Edge-to-Edge Mitral Valve Repair in Patients With Maintained Sinus Rhythm. JACC Cardiovasc Interv. 2019 Jan 28;12(2):214-216. doi: 10.1016/j.jcin.2018.11.009. No abstract available.
- Results publication: PubMed 28368846Seeger J, Muller P, Gonska B, Scharnbeck D, Markovic S, Walcher D, Rottbauer W, Wohrle J. Percutaneous Mitral Valve Repair With the MitraClip in Primary Compared With Secondary Mitral Valve Regurgitation Using the Mitral Valve Academic Research Consortium Criteria. J Invasive Cardiol. 2017 Apr;29(4):145-150.
- 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.
Jochen Woehrle, MD principal investigator
University Hospital Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CE certified mitral valve repair systems in people with Mitral Valve Regurgitation, run by University of Ulm 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 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: finished, as of the sponsor's last update on 28 Apr 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?
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?
Major adverse cerebral and cardiac events (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03104660, which also lists 2 linked publications.
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 28 Apr 2020.