Mitral RegurgitationMVRepairNCT02853955
MitraClip® After Surgical Mitral Valve Repair
An observational study of Mitral Regurgitation, run by LMU Klinikum at 1 site in Germany.
Trial summary
Percutaneous edge-to-edge repair of the mitral valve has been shown to be a safe and effective alternative treatment option for selected patients at high risk for cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- Percutaneous edge-to-edge repair of the mitral valve
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to Nov 2016
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients treated with a MitraClip® after sMVR
Who may be able to join
- All patients with recurrent mitral regurgitation treated with a MitraClip®.
Who cannot join
- Patient with endocarditis,
- Patients with torn mitral valve ring.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Munich University Hospital
Munich, Bavaria, 81377
Daniel Braun, MD, +49894400 ext. 73052, Daniel.Braun@med.uni-muenchen.de
Joerg Hausleiter, MD, +49894400 ext. 72360, Joerg.Hausleiter@med.uni-muenchen.de
About this study
Official title: MitraClip® for the Treatment of Recurrent Severe Mitral Regurgitation After Surgical Mitral Valve Repair
Percutaneous edge-to-edge repair of the mitral valve has been shown to be a safe and effective alternative treatment option for selected patients at high risk for cardiac surgery. Patients with recurrent mitral regurgitation after surgical mitral valve repair (sMVR) are per se at increased risk for another cardiac surgery. The purpose of this multicenter retrospective analysis of patients treated with a MitraClip® after sMVR, is to evaluate the effectiveness and durability of this minimally invasive treatment option in this subset of patients.
Read the detailed description
In this multicenter retrospective analysis of MitraClip® cases after MVR the effectiveness and durability of this minimally invasive treatment option in this subset of patients will be evaluated.
- Conditions
- Mitral Regurgitation
- Being tested
- Percutaneous edge-to-edge repair of the mitral valve
- 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.
Percutaneous edge-to-edge repair of the mitral valveDevice
MitraClip in patients with recurrent MI after surgical mitral valve repair.
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 1 year
MR (mitral regurgitation) grade after clip treatment
Scale 0-4
Measured: 1 year
Secondary outcomes (10)
MR (mitral regurgitation) grade at latest follow up
Scale 0-4
Measured: 1 year
NYHA status at latest follow up
Measured: 1 year
Distance in 6 minute walk test at latest follow up
Measured: 1 year
LVEF (left ventricular ejection fraction) at latest follow up
Measured: 1 year
LVEDV (left ventricular enddiastolic volume) at latest follow up
Measured: 1 year
LVEDD (lef ventricular enddiastolic diameter) at latest follow up
Measured: 1 year
Mean mitral valve gradient
Measured: 1 year
Procedural complications
Measured: index procedure
Death, recurrent mitral regurgitation grade > 2, repeat intervention/operation of mitral valve
combined endpoint defined as freedom from each Event (death, MR grade >2 or reintervention/Operation)
Measured: 1 year
Clip success based on type of sMVR
success defined as reduction of 1 MR grade (scale 0-4)
Measured: index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Braun, MD, LMU Klinikum
- Investigators
- Jörg Hausleiter, MD, Study chair, LMU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853955
- Sponsor's protocol ID
- GE IDE MucS001-16
- Acronym
- MVRepair
- Status last verified
- Jul 2016
- First submitted
- 31 Mar 2016
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MitraClip® for the Treatment of Recurrent Severe Mitral Regurgitation After Surgical Mitral Valve Repair
- ClinicalTrials.gov ID
- NCT02853955
- Acronym / sponsor ID
- MVRepair / GE IDE MucS001-16
- Conditions
- Mitral Regurgitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 3 Aug 2016 (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.
Percutaneous edge-to-edge repair of the mitral valve has been shown to be a safe and effective alternative treatment option for selected patients at high risk for cardiac surgery. Patients with recurrent mitral regurgitation after surgical mitral valve repair (sMVR) are per se at increased risk for another cardiac surgery. The purpose of this multicenter retrospective analysis of patients treated with a MitraClip® after sMVR, is to evaluate the effectiveness and durability of this minimally invasive treatment option in this subset of patients.
Detailed description
In this multicenter retrospective analysis of MitraClip® cases after MVR the effectiveness and durability of this minimally invasive treatment option in this subset of patients will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated with a MitraClip® after sMVR
Key inclusion criteria (1 listed)
- All patients with recurrent mitral regurgitation treated with a MitraClip®.
Key exclusion criteria (2 listed)
- Patient with endocarditis,
- Patients with torn mitral valve ring.
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 |
|---|---|---|
| Percutaneous edge-to-edge repair of the mitral valveMitraClip in patients with recurrent MI after surgical mitral valve repair. | Device | – |
Primary outcome
Survival
Time frame: 1 year
MR (mitral regurgitation) grade after clip treatment
Time frame: 1 year
Scale 0-4
10 secondary outcomes
MR (mitral regurgitation) grade at latest follow up
Time frame: 1 year
NYHA status at latest follow up
Time frame: 1 year
Distance in 6 minute walk test at latest follow up
Time frame: 1 year
LVEF (left ventricular ejection fraction) at latest follow up
Time frame: 1 year
LVEDV (left ventricular enddiastolic volume) at latest follow up
Time frame: 1 year
LVEDD (lef ventricular enddiastolic diameter) at latest follow up
Time frame: 1 year
Mean mitral valve gradient
Time frame: 1 year
Procedural complications
Time frame: index procedure
Death, recurrent mitral regurgitation grade > 2, repeat intervention/operation of mitral valve
Time frame: 1 year
Clip success based on type of sMVR
Time frame: index procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
- 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.
Jörg Hausleiter, MD study chair
LMU Munich
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 Regurgitation, run by LMU Klinikum 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 1 inclusion and 2 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 1 Sep 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Braun, MD (+49 89 4400 ext. 73052, Daniel.Braun@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 1 year). The study lists 2 primary outcomes in all. 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 1 Sep 2016.