Mitral Valve ProlapsePhase 1SJM PMVrNCT01500148
St. Jude Medical Percutaneous Mitral Valve Repair Study
A Phase 1 study testing PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr) in people with Mitral Valve Prolapse, run by Abbott Medical Devices at 1 site in United Kingdom.
Trial summary
The purpose of this proof-of-concept study is to assess the relative safety and feasibility of the SJM Percutaneous Mitral Valve Repair (PMVr) Device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Prolapse
- What is being tested?
- PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2011to Aug 2012
- Phase
- Phase 1
- 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
- Subject has symptomatic or asymptomatic moderate (2+) or severe (3-4+) mitral regurgitation.
- Subject has an ejection fraction (EF) ≥ 30%.
- Subject is of legal age (≥18 years old).
- Subject is planned to undergo surgical repair or replacement of the mitral valve for symptomatic or asymptomatic posterior leaflet mitral prolapse.
Who cannot join
- Subject requires a complex mitral valve repair or has isolated anterior prolapse.
- Subject has mitral valve stenosis in which the annulus opening is <10mm. Subject has valve disease other than mitral which requires surgical intervention.
- Subject requires a concomitant procedure.
- Subject has a pre-existing prosthetic valve in any position.
- Subject had stenting or PCI within 6 months before the planned procedure, or is anticipated to require stenting or PCI within 6 months post-procedure.
- Subject has calcification of the mitral leaflets or annulus which in the medical opinion of the surgical investigator would limit repair and /or implantation of the investigational device.
Show all 13Show fewer
- Subject has renal insufficiency or is on chronic dialysis.
- Subject has had a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months.
- Subject has a history of endocarditis or has active endocarditis.
- Subject has a history of autoimmune disease.
- Subject has significant known carotid artery disease.
- Subject has an aorto-mitral angle of <110 degrees.
- Subject has hypertrophic obstructive cardiomyopathy (HOCM's Disease).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Assessment of the St. Jude Medical (SJM) Percutaneous Mitral Valve Repair (PMVr) Device Concept
The purpose of this proof-of-concept study is to assess the relative safety and feasibility of the SJM Percutaneous Mitral Valve Repair (PMVr) Device.
Read the detailed description
Subjects will be followed-up through 6 weeks post implantation.
- Conditions
- Mitral Valve Prolapse
- Being tested
- PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)
- Keywords
- Mitral Valve Prolapse, Mitral Valve Disease, Mitral Valve Regurgitation, Mitral Valve Insufficiency, Mitral Valve Incompetence, Percutaneous Mitral Valve Repair, Posterior leaflet prolapse, Mitral valve degeneration
- Medical subject headings
- Mitral Valve Prolapse, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)Device
A maximum of ten (10) subjects will receive a percutaneous mitral valve clip procedure.
| Study group | Role | What they receive |
|---|---|---|
| Intevention-PMVr Procedure | Experimental | Not described Receives: Device: PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device and Procedural Success
The primary objective is to evaluate the technical feasibility and acute device deployment characteristics of the SJM PMVr Device.
Technical feasibility and deployment characteristics will be defined as:
- The ability of the delivery system to access the mitral valve
- The ability of the device to capture mitral valve (MV) leaflet tissue
- Ability to plicate MV leaflet tissue
- The clip is able to be deployed in MV leaflet tissue
- The delivery system is able to be removed.
Measured: During the investigational procedure
Secondary outcomes (1)
Quantification of SAEs reported that are unique to the investigational procedure
The secondary objective is to evaluate safety of the SJM PMVr device by summarizing SAEs unique to accessing the valve, placing the clip, and removing the delivery system.
Measured: Through 6 weeks post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve ProlapseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500148
- Sponsor's protocol ID
- 1101
- Acronym
- SJM PMVr
- Status last verified
- Feb 2019
- First submitted
- 6 Dec 2011
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of the St. Jude Medical (SJM) Percutaneous Mitral Valve Repair (PMVr) Device Concept
- ClinicalTrials.gov ID
- NCT01500148
- Acronym / sponsor ID
- SJM PMVr / 1101
- Conditions
- Mitral Valve Prolapse
- Keywords
- Mitral Valve Prolapse, Mitral Valve Disease, Mitral Valve Regurgitation, Mitral Valve Insufficiency, Mitral Valve Incompetence, Percutaneous Mitral Valve Repair, Posterior leaflet prolapse, Mitral valve degeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 28 Dec 2011 (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 purpose of this proof-of-concept study is to assess the relative safety and feasibility of the SJM Percutaneous Mitral Valve Repair (PMVr) Device.
Detailed description
Subjects will be followed-up through 6 weeks post implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intevention-PMVr Procedure | Experimental | Device: PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject has symptomatic or asymptomatic moderate (2+) or severe (3-4+) mitral regurgitation.
- Subject has an ejection fraction (EF) ≥ 30%.
- Subject is of legal age (≥18 years old).
- Subject is planned to undergo surgical repair or replacement of the mitral valve for symptomatic or asymptomatic posterior leaflet mitral prolapse.
Key exclusion criteria (13 listed)
- Subject requires a complex mitral valve repair or has isolated anterior prolapse.
- Subject has mitral valve stenosis in which the annulus opening is <10mm. Subject has valve disease other than mitral which requires surgical intervention.
- Subject requires a concomitant procedure.
- Subject has a pre-existing prosthetic valve in any position.
- Subject had stenting or PCI within 6 months before the planned procedure, or is anticipated to require stenting or PCI within 6 months post-procedure.
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 |
|---|---|---|
| PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)A maximum of ten (10) subjects will receive a percutaneous mitral valve clip procedure. | Device | Intevention-PMVr Procedure |
Primary outcome
Device and Procedural Success
Time frame: During the investigational procedure
The primary objective is to evaluate the technical feasibility and acute device deployment characteristics of the SJM PMVr Device. Technical feasibility and deployment characteristics will be defined as: * The ability of the delivery system to access the mitral valve * The ability of the device to capture mitral valve (MV) leaflet tissue * Ability to plicate MV leaflet tissue * The clip is able to be deployed in MV leaflet tissue * The delivery system is able to be removed.
1 secondary outcome
Quantification of SAEs reported that are unique to the investigational procedure
Time frame: Through 6 weeks post-implantation
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 4 Feb 2019.
Related trials for Mitral Valve Prolapse
Active, not recruitingPhase 3
Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse
Mitral Valve Prolapse, Ventricular Arrhythmias and Cardiac Arrest
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
Active, not recruiting
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
Mitral Valve Regurgitation
RecruitingObservational study
Mitral Valve Prolapse Arrhythmic Risk
Mitral Valve Prolapse, Ventricular Arrhythmias and Cardiac Arrest
RecruitingObservational study
Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse
Mitral Valve Prolapse
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr) in people with Mitral Valve Prolapse, run by Abbott Medical Devices at 1 site in United Kingdom.
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 4 inclusion and 13 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 4 Feb 2019. 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 United Kingdom. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Device and Procedural Success (time frame: During the investigational procedure). 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 4 Feb 2019.