Mitral Valve ReconstructionNCT03798015
Neurologic Outcome After Mitral Valve Surgery
An observational study of Mitral Valve Reconstruction, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Reconstructive mitral valve surgery is increasingly done by minimal- invasive anterolateral thoracotomy technique in contrast to surgical approach by sternotomy. The minimal invasive approach is favourable regarding surgical trauma, length of hospital stay and amount of blood loss. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitral Valve Reconstruction
- What is being tested?
- mitral valve surgery
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2009to Dec 2021
- 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 a surgical mitral valve reconstruction or replacement at the University Hospital Basel from 2009 until today
Who may be able to join
- surgery for mitral valve (reconstruction or replacement) (maybe combined with surgery for tricuspid valve and/ or surgery for atrial septal defects and/or patent foramen ovale)
Who cannot join
- other surgical interventions then the surgical interventions mentioned in the inclusion criteria
- pre- existing neurological deficit; neurologic limitation in daily life
- emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Reconstructive mitral valve surgery is increasingly done by minimal- invasive anterolateral thoracotomy technique in contrast to surgical approach by sternotomy. The minimal invasive approach is favourable regarding surgical trauma, length of hospital stay and amount of blood loss.
This study is to investigate the neurological outcome after minimal- invasive mitral valve surgery compared to open mitral valve surgery by sternotomy.
Pre-, intra- and postsurgical data from mitral valve surgery derived from the Basel mitral valve registry (collected from 2009 until now) will be analyzed.
- Conditions
- Mitral Valve Reconstruction
- Being tested
- mitral valve surgery
- Keywords
- mitral valve surgery, mitral valve stenosis, mitral valve insufficiency, minimal invasive mitral valve surgery, neurological outcome
- Medical subject headings
- Mitral Valve Stenosis, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitral valve surgeryOther
assessment of ischemic or hemorrhagic stroke subsequent to mitral valve surgery
| Study group | Role | What they receive |
|---|---|---|
| mitral valve surgery | outcome of mitral valve surgery (stroke yes or no) Receives: Other: mitral valve surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurence of stroke (yes/ no) subsequent to mitral valve surgery
assessment of ischemic or hemorrhagic stroke subsequent to mitral valve surgery
Measured: post surgical from day of surgery until day of discharge from hospital (approx. 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study startFeb 2009
- Primary completionDec 2021
- Study completionDec 2021
Why it stopped: resource issues on site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve ReconstructionStudies 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Grapow, Prof. Dr. MD, Principal investigator, Klinik für Herzchirurgie, Universitätsspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798015
- Sponsor's protocol ID
- 2018-02143; ch18Grapow3
- Other IDs
- 2018
- Status last verified
- Apr 2022
- First submitted
- 7 Jan 2019
- Last updated
- 20 Apr 2022
- 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 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurologic Outcome After Mitral Valve Surgery
- ClinicalTrials.gov ID
- NCT03798015
- Acronym / sponsor ID
- 2018-02143; ch18Grapow3
- Conditions
- Mitral Valve Reconstruction
- Keywords
- mitral valve surgery, mitral valve stenosis, mitral valve insufficiency, minimal invasive mitral valve surgery, neurological outcome
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: resource issues on site
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Feb 2009 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 9 Jan 2019 (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.
Reconstructive mitral valve surgery is increasingly done by minimal- invasive anterolateral thoracotomy technique in contrast to surgical approach by sternotomy. The minimal invasive approach is favourable regarding surgical trauma, length of hospital stay and amount of blood loss.
This study is to investigate the neurological outcome after minimal- invasive mitral valve surgery compared to open mitral valve surgery by sternotomy.
Pre-, intra- and postsurgical data from mitral valve surgery derived from the Basel mitral valve registry (collected from 2009 until now) will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mitral valve surgery | – | Other: mitral valve surgeryoutcome of mitral valve surgery (stroke yes or no) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients undergoing a surgical mitral valve reconstruction or replacement at the University Hospital Basel from 2009 until today
Key inclusion criteria (1 listed)
- surgery for mitral valve (reconstruction or replacement) (maybe combined with surgery for tricuspid valve and/ or surgery for atrial septal defects and/or patent foramen ovale)
Key exclusion criteria (3 listed)
- other surgical interventions then the surgical interventions mentioned in the inclusion criteria
- pre- existing neurological deficit; neurologic limitation in daily life
- emergency surgery
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 surgeryassessment of ischemic or hemorrhagic stroke subsequent to mitral valve surgery | Other | mitral valve surgery |
Primary outcome
occurence of stroke (yes/ no) subsequent to mitral valve surgery
Time frame: post surgical from day of surgery until day of discharge from hospital (approx. 2 weeks)
assessment of ischemic or hemorrhagic stroke subsequent to mitral valve surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
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Recruiting
Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation
Heart Failure - NYHA II - IV, Mitral Regurgitation Functional
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. Dr. MD principal investigator
Klinik für Herzchirurgie, Universitätsspital 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 Reconstruction, 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 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: withdrawn, as of the sponsor's last update on 20 Apr 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
occurence of stroke (yes/ no) subsequent to mitral valve surgery (time frame: post surgical from day of surgery until day of discharge from hospital (approx. 2 weeks)). 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 20 Apr 2022.