Mitral Valve DiseaseNCT03587688
Registry for Mitral Valve Surgery at Department of Cardiac Surgery University Hospital of Basel/ Switzerland
An observational study of Mitral Valve Disease and Mitral Valve Surgery, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
A registry is installed to collect (pre-, intra- and postoperative) data on patients undergoing mitral valve surgery at the Department for Cardiac Surgery of Universitätsspital Basel/ Switzerland since 2009. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitral Valve Disease, Mitral Valve Surgery
- What is being tested?
- mitral valve surgery
- Type of treatment
- Surgery or procedure
- How many people
- 701 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Apr 2018to 6 Dec 2024
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients undergoing mitral valve surgery at the Department for Cardiac Surgery of Universitätsspital Basel/ Switzerland since 2009
Who may be able to join
- patients undergoing mitral valve surgery at the Department for Cardiac Surgery of Universitätsspital Basel/ Switzerland since 2009
Who cannot join
- patients refusing consent for data use
Trial locations and contacts
1 site in 1 country.
About this study
A registry is installed to collect (pre-, intra- and postoperative) data on patients undergoing mitral valve surgery at the Department for Cardiac Surgery of Universitätsspital Basel/ Switzerland since 2009. Retrospective data (since 2009) as well as prospective data are included in this ongoing registry to analyse the development of mitral valve surgery at the Department of Cardiac Surgery University Hospital of Basel/ Switzerland.
- Conditions
- Mitral Valve Disease, Mitral Valve Surgery
- Being tested
- mitral valve surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitral valve surgeryProcedure or surgery
pre-, intra- and postoperative data on patients undergoing mitral valve surgery at the Department for Cardiac Surgery of Universitätsspital Basel/ Switzerland since 2009
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between technique of mitral valve surgery and postoperative mitral valve pressure gradient
correlation between technique of mitral valve surgery and postoperative mitral valve pressure gradient
Measured: 4 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start28 Apr 2018
- Primary completion6 Dec 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Other
- Enrolment
- 701 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Grapow, Prof. MD, Principal investigator, University Hospital Basel, CH-4031 Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587688
- Sponsor's protocol ID
- 2018-00246,ch18Grapow
- Other IDs
- 2018
- Status last verified
- Dec 2024
- First submitted
- 3 Jul 2018
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry for Mitral Valve Surgery at Department of Cardiac Surgery University Hospital of Basel/ Switzerland
- ClinicalTrials.gov ID
- NCT03587688
- Acronym / sponsor ID
- 2018-00246,ch18Grapow
- Conditions
- Mitral Valve Disease, Mitral Valve Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 701 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 28 Apr 2018 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 16 Jul 2018 (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.
A registry is installed to collect (pre-, intra- and postoperative) data on patients undergoing mitral valve surgery at the Department for Cardiac Surgery of Universitätsspital Basel/ Switzerland since 2009. Retrospective data (since 2009) as well as prospective data are included in this ongoing registry to analyse the development of mitral valve surgery at the Department of Cardiac Surgery University Hospital of Basel/ Switzerland.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 4 Weeks
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients undergoing mitral valve surgery at the Department for Cardiac Surgery of Universitätsspital Basel/ Switzerland since 2009
Key inclusion criteria (1 listed)
- patients undergoing mitral valve surgery at the Department for Cardiac Surgery of Universitätsspital Basel/ Switzerland since 2009
Key exclusion criteria (1 listed)
- patients refusing consent for data use
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 |
|---|---|---|
| mitral valve surgerypre-, intra- and postoperative data on patients undergoing mitral valve surgery at the Department for Cardiac Surgery of Universitätsspital Basel/ Switzerland since 2009 | Procedure or surgery | – |
Primary outcome
correlation between technique of mitral valve surgery and postoperative mitral valve pressure gradient
Time frame: 4 weeks post surgery
correlation between technique of mitral valve surgery and postoperative mitral valve pressure gradient
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 16 Dec 2024.
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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.
Martin Grapow, Prof. MD principal investigator
University Hospital Basel, CH-4031 Basel
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 Disease and Mitral Valve Surgery, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 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 16 Dec 2024. 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 Switzerland. 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?
correlation between technique of mitral valve surgery and postoperative mitral valve pressure gradient (time frame: 4 weeks post surgery). 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 16 Dec 2024.