Mitral Valve RegurgitationDOCK 1NCT02719912
Mitral Valve Replacement With MValve Dock and Lotus
A study testing mitral valve replacement in people with Mitral Valve Regurgitation, run by MValve Technologies Ltd at 4 sites in 4 countries.
Trial summary
This study evaluates the MValve mitral prosthesis in conjunction with a Lotus transcatheter heart valve (THV) for mitral valve replacement in subjects at high risk for conventional mitral valve replacement or repair surgery. 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?
- mitral valve replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jun 2016to Jul 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
- Symptomatic ≥3+ degenerative or functional mitral regurgitation of either ischemic or non-ischemic etiology based by a qualifying echocardiography obtained within 90 days prior to the procedure.
- New York Heart Association (NYHA) Functional Class III or IV.
- High risk for conventional open mitral valve repair or replacement surgery in the consideration of the site Heart Team.
- Left Ventricular Ejection Fraction (LVEF) is ≥30% within 30 days prior to the procedure.
- Mitral valve annular commissure to commissure (C/C) dimension between 30-35 mm by echocardiography.
- Left atrial diameter <5.5 cm by echocardiography
Who cannot join
- Prior mitral valve replacement or repair surgery.
- Prior transapical surgery.
- Severe aortic or tricuspid valve disease. - Severe symptomatic carotid stenosis (>70% by ultrasound).
- ACC/AHA Stage D heart failure.
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.
- Infiltrative cardiomyopathies (amyloidosis, hemochromatosis, sarcoidosis).
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- Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction.
- Severe mitral annular calcification.
- Glomerular filtration rate (GFR) < 30.
- Hemodynamic instability defined as systolic pressure < 90 mm Hg with or without afterload reduction, cardiogenic shock, or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device, or any mechanical heart assistance.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Brazil1 site
Dante Pazzenese Institute of Cardiology
Sau Paulo
Alexander Abizaid, MD
aabizaid@uol.com.br
France1 site
Clinique Pasteur
Toulouse
Frederic Petit, fpetit@clinique-pasteur.com
Didier Tchetche, MD
Germany1 site
University of Bonn - Medizinische Klinik und Poliklinik II
Bonn
Kaja Twelker, MD, kaja.twelker@ukb.uni-bonn.de
Georg Nickenig, MD
Poland1 site
University of Poznan
Poznan
Maciej Lesiak, MD
maciej.lesiak@skpp.edu.pl
About this study
Official title: Mitral Valve Replacement With the MValve Dock and A Percutaneous Transcatheter Heart Valve
This study evaluates the MValve mitral prosthesis in conjunction with a Lotus transcatheter heart valve (THV) for mitral valve replacement in subjects at high risk for conventional mitral valve replacement or repair surgery.
Read the detailed description
This study is a prospective first in man feasibility study intended to evaluate preliminary safety and effectiveness of the MValve Mitral Dock with Lotus transcatheter heart valve for mitral valve replacement in subjects who are at high risk for surgical valve repair or replacement.
The surgical technique adapts the valve-in-valve approach for mitral replacement in degenerated mitral prostheses to failing native mitral valves. The MValve Dock is designed to provide a structural platform within the mitral annulus so that the Lotus THV can be implanted in a secure fashion in the mitral annulus. The investigational device anchors to the mitral annulus commissures, sparing the native valve leaflets and sub annular apparatus. This study is designed to treat subjects with moderate-to-severe MR who are not deemed candidates for mitral valve surgery.
- Conditions
- Mitral Valve Regurgitation
- Being tested
- mitral valve replacement
- 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.
mitral valve replacementDevice
transcatheter mitral valve replacement
| Study group | Role | What they receive |
|---|---|---|
| Valve Replacement | Experimental | Mitral valve replacement Receives: Device: mitral valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite serious adverse cardiac events and stroke
death, myocardial infarction, stroke, repeat surgery
Measured: 30 days
Secondary outcomes (1)
Mitral regurgitation grade
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MValve Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719912
- Sponsor's protocol ID
- CIP 01-2015
- Acronym
- DOCK 1
- Status last verified
- Mar 2016
- First submitted
- 21 Mar 2016
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitral Valve Replacement With the MValve Dock and A Percutaneous Transcatheter Heart Valve
- ClinicalTrials.gov ID
- NCT02719912
- Acronym / sponsor ID
- DOCK 1 / CIP 01-2015
- Conditions
- Mitral Valve Regurgitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- MValve Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 25 Mar 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.
This study evaluates the MValve mitral prosthesis in conjunction with a Lotus transcatheter heart valve (THV) for mitral valve replacement in subjects at high risk for conventional mitral valve replacement or repair surgery.
Detailed description
This study is a prospective first in man feasibility study intended to evaluate preliminary safety and effectiveness of the MValve Mitral Dock with Lotus transcatheter heart valve for mitral valve replacement in subjects who are at high risk for surgical valve repair or replacement.
The surgical technique adapts the valve-in-valve approach for mitral replacement in degenerated mitral prostheses to failing native mitral valves. The MValve Dock is designed to provide a structural platform within the mitral annulus so that the Lotus THV can be implanted in a secure fashion in the mitral annulus. The investigational device anchors to the mitral annulus commissures, sparing the native valve leaflets and sub annular apparatus. This study is designed to treat subjects with moderate-to-severe MR who are not deemed candidates for mitral valve surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valve Replacement | Experimental | Device: mitral valve replacementMitral valve replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Symptomatic ≥3+ degenerative or functional mitral regurgitation of either ischemic or non-ischemic etiology based by a qualifying echocardiography obtained within 90 days prior to the procedure.
- New York Heart Association (NYHA) Functional Class III or IV.
- High risk for conventional open mitral valve repair or replacement surgery in the consideration of the site Heart Team.
- Left Ventricular Ejection Fraction (LVEF) is ≥30% within 30 days prior to the procedure.
- Mitral valve annular commissure to commissure (C/C) dimension between 30-35 mm by echocardiography.
Key exclusion criteria (10 listed)
- Prior mitral valve replacement or repair surgery.
- Prior transapical surgery.
- Severe aortic or tricuspid valve disease. - Severe symptomatic carotid stenosis (>70% by ultrasound).
- ACC/AHA Stage D heart failure.
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.
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 replacementtranscatheter mitral valve replacement | Device | Valve Replacement |
Primary outcome
Composite serious adverse cardiac events and stroke
Time frame: 30 days
death, myocardial infarction, stroke, repeat surgery
1 secondary outcome
Mitral regurgitation grade
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
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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.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mitral valve replacement in people with Mitral Valve Regurgitation, run by MValve Technologies Ltd at 4 sites in 4 countries.
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 6 inclusion and 10 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 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil, France, Germany, Poland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite serious adverse cardiac events and stroke (time frame: 30 days). 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 25 Mar 2016.