Severe Degenerative Mitral RegurgitationNCT01519050
Predictors of Postoperative Left Ventricular Function in Patients Undergoing Mitral Valve Repair for Severe Degenerative Mitral Regurgitation
An observational study of Severe Degenerative Mitral Regurgitation, run by University of Zurich at 1 site in Switzerland.
Trial summary
The aim of the study is to investigate whether a predictive score (combination of several validated predictors) better predicts postoperative left ventricular function than any single predictor in patients undergoing mitral valve repair for degenerative mitral regurgitation. A single center, prospective cohort study Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Severe Degenerative Mitral Regurgitation
- What is being tested?
- mitral valve repair
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2011to May 2014
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 patients with mitral valve proplapse ondergoing mitral valve repair for severe mitral regurgitation
Who may be able to join
- Age 18- 85 years
- Patients with severe degenerative mitral regurgitation undergoing mitral valve repair at our institution
Who cannot join
- Functional or ischemic mitral regurgitation
- Presence of relevant (symptomatic) Coronary Artery Disease
- Inability of exercising on semi supine bicycle
Trial locations and contacts
1 site in 1 country.
Patric Biaggi, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Division of Cardiology
Zurich, Canton of Zurich, 8091
About this study
The aim of the study is to investigate whether a predictive score (combination of several validated predictors) better predicts postoperative left ventricular function than any single predictor in patients undergoing mitral valve repair for degenerative mitral regurgitation.
A single center, prospective cohort study
- Conditions
- Severe Degenerative Mitral Regurgitation
- Being tested
- mitral valve repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitral valve repairBehavioural
Mitral valve repair in patients with degenerative mitral regurgitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Degenerative Mitral 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
- Investigators
- Patric Biaggi, MD, Senior physican, Principal investigator, University Hospital Zurich, Division of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519050
- Sponsor's protocol ID
- KEK ZH 2011- 0274
- Status last verified
- Jan 2012
- First submitted
- 23 Jan 2012
- Last updated
- 26 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Postoperative Left Ventricular Function in Patients Undergoing Mitral Valve Repair for Severe Degenerative Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT01519050
- Acronym / sponsor ID
- KEK ZH 2011- 0274
- Conditions
- Severe Degenerative Mitral Regurgitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- Nov 2011
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 26 Jan 2012 (estimated)
- 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.
The aim of the study is to investigate whether a predictive score (combination of several validated predictors) better predicts postoperative left ventricular function than any single predictor in patients undergoing mitral valve repair for degenerative mitral regurgitation.
A single center, prospective cohort study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients with mitral valve proplapse ondergoing mitral valve repair for severe mitral regurgitation
Key inclusion criteria (2 listed)
- Age 18- 85 years
- Patients with severe degenerative mitral regurgitation undergoing mitral valve repair at our institution
Key exclusion criteria (3 listed)
- Functional or ischemic mitral regurgitation
- Presence of relevant (symptomatic) Coronary Artery Disease
- Inability of exercising on semi supine bicycle
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 repairMitral valve repair in patients with degenerative mitral regurgitation | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
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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.
Patric Biaggi, MD contact
Patric Biaggi, MD, Senior physican principal investigator
University Hospital Zurich, Division of Cardiology
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 Severe Degenerative Mitral Regurgitation, run by University of Zurich 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 2 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: status not confirmed, as of the sponsor's last update on 26 Jan 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ines Bühler, Study Coordinator (+41 (0)44 255 11 11, ines.buehler@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 26 Jan 2012.