Functional Mitral RegurgitationNCT01852149
Mitralign Percutaneous Annuloplasty First in Man Study
A study testing MPAS Implant in people with Functional Mitral Regurgitation, run by Mitralign, Inc. at 5 sites in 3 countries.
Trial summary
The purpose of this study is to assess the safety and feasibility of the Mitralign Percutaneous Annuloplasty System in humans for the treatment of chronic functional mitral regurgitation. No formal test of hypothesis is proposed for this trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Mitral Regurgitation
- What is being tested?
- MPAS Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Aug 2009to Sep 2015
- 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
- Patient with chronic functional mitral regurgitation.
- Patient is greater than 18 years old.
- Documented symptoms of CHF - NYHA II-IV.
- Left ventricular ejection fraction between 30 and 60 percent.
- Acceptable candidate for cardiac surgery and/or blood transfusion.
- Patient or legal guardian understands the study requirements and the treatment procedures and provides written Informed Consent before any study- specific tests or procedures are performed.
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- Willing to comply with all specified follow-up evaluations.
- Mitral regurgitation grade 2.
- Patient has a mitral plane to apex dimension 5 cm.
- Structurally normal mitral valve.
Who cannot join
- Patient with significant organic mitral valve pathology such as myxomatous degeneration, mitral valve prolapse or flail leaflets moderate or severe valve calcifications, ruptured papillary muscles or ruptured chordae tendinae.
- Previous mitral valve repair or mitral valve replacement.
- Patient with mitral stenosis.
- Patient with moderate or severe aortic stenosis and or moderate or severe aortic regurgitation.
- Patient with endocarditis.
- MI within 30 days prior to the index procedure.
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- Unstable angina.
- Percutaneous Coronary Intervention within 30 days prior to the index procedure.
- CABG within 3 months prior to the index procedure.
- Planned PCI less than 30 days post index procedure.
- Planned CABG within 6 months post index procedure.
- Patient with severe, multivessel coronary artery disease and who cannot tolerate sudden hemodynamic changes or acute hemoglobin drop.
- Cardiogenic Shock characterized by systolic pressure less than 80 mm Hg and or central filling pressure greater than 20 mm Hg, or cardiac index less than 1.8 liters per minute per m2 or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure greater than 80 mm Hg and a cardiac index greater than 1.8 liters per minute per m2.
- Patient with peripheral vascular disease or tortuousity that would prevent percutaneous access with a 14 Fr introducer sheath or intervention with the Mitralign system.
- Cerebrovascular Accident within the past 6 months.
- Acute or chronic renal dysfunction creatinine greater than 2.0mg per dl or 177µmolper dl
- Anemia Hb greater than 10 g per dl.
- Thrombocytopenia platelet count less than 100,000 per mm3) or thrombocytosis platelet greater than 750,000 per mm3).
- Bleeding disorders or hypercoaguable state.
- Active peptic ulcer or active gastrointestinal bleeding.
- Contraindication to therapy with antiplatelet or anticoagulant drugs.
- Contraindications to or patient's refusal of blood transfusions.
- Known allergy to stainless steel or platinum iridium or polyester.
- Any prior true anaphylactic reaction to contrast agents defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure.
- Pregnancy or female of childbearing potential with a positive pregnancy test within 24 hours before the index procedure or undergoing any angiography or x-ray, or lactating.
- Co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study.
- Life expectancy of less than 24 months due to other medical condition.
- Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
- Patient with impaired judgment.
- Patient having to undergo emergency treatment.
- Thrombus in left ventricle or left atrium.
- Echocardiographic evidence of congenital, pericardial or infiltrative heart disease.
- Suboptimal echocardiographic (TTE) windows, leading to incomplete quantification of FMR or anatomic assessment.
- Significant subvalvular trabecularization, muscle bridges and pockets
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Germany3 sites
Universitats Klinikum Bonn
Bonn, D-53127
Elisabeth-Krankenhaus Essen
Essen, D-45138
Asklepios Klinik St Georg
Hamburg, D-2009
About this study
Official title: Mitralign Percutaneous Annuloplasty First in Man (FIM) Study
The purpose of this study is to assess the safety and feasibility of the Mitralign Percutaneous Annuloplasty System in humans for the treatment of chronic functional mitral regurgitation. No formal test of hypothesis is proposed for this trial.
Read the detailed description
The primary objective of this study is to test the ability to safely perform mitral posterior annulus plication with the Mitralign System in eligible patients with chronic functional MR using an endovascular approach. Data obtained from this study, combined with extensive pre-clinical data, will provide important technical and early clinical outcome information that will drive the next phase of clinical investigation and potentially enhance the future design of the Mitralign Percutaneous Annuloplasty System. It is anticipated that the Mitralign System will one day provide physicians with a safe and effective alternative therapy for treating patients who are candidates for mitral valve repair and offer a primary therapy option for patients superior to current treatment modalities.
This is a single-arm, multi-center, prospective study designed to test the safety and feasibility of the MPAS to treat patients with chronic, functional MR by performing plication of the posterior mitral annulus.
Up to a total of 36 patients with chronic functional mitral regurgitation will be enrolled: 1.) Up to 16 patients (12 patients + 1 roll-in patient per site) will be enrolled in Phase I. Up to thirty-four (34) patients will be enrolled in Phase II (MITRALIGN ADVANTAGE). All patients will be followed for 24 months. Up to 5 sites in Europe and South America will participate.
Study procedures include implantation of the MPAS, Trans-Esophogeal Echo, Trans-Thoracic Echo, Blood test, 6-min walk, Quality of Life, Chest X-ray and ECG.
Descriptive Statistics will be conducted for this study.
- Conditions
- Functional Mitral Regurgitation
- Being tested
- MPAS Implant
- Keywords
- Mitral Valve Regurgitation, Coaptation, Mitral Valve Repair, Plication, Leaflet, Annulus, Mitral Annuloplasty
- 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.
MPAS ImplantDevice
Also called Bident, Plication, Mitral annuloplasty, annulus
The Mitralign System consists of a set of catheters that enable the physician to position and place sutures and anchors through the posterior (back) annulus of the mitral valve under the guidance of echocardiography and fluoroscopy. Once the anchored sutures are in place, the sutures are pulled together. When the valve leaflets are close together, the sutures are locked with at least one stainless steel lock. The Bident Translation Catheter allows implantation of two pairs of pledgets. Each pair of pledgets plicates the annulus and then the pledgets are locked together from the ventricular side with a lock.
| Study group | Role | What they receive |
|---|---|---|
| MPAS Implant | Experimental | MPAS Implant Receives: Device: MPAS Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary study endpoint will assess acute safety defined as the incidence of Device-related NACE (net adverse clinical events which includes Device Related Mortality, MI, Cardiac Tamponade and stroke) at 30 days
The primary study endpoint will assess acute safety using a composite clinical endpoint of device-related net adverse cardiac events (NACE) at 30 days. The components of NACE are defined as the occurrence of device related mortality, myocardial infarction, cardiac tamponade, cardiac surgery or stroke in per protocol population
Measured: 30 Days post implant
Secondary outcomes (1)
Echocardiographic measures
Measurement of Ventricular diameter and Mitral Regurgitant Grade
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startAug 2009
- Primary completionMar 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mitralign, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medstar Health Research Institute, The Cooper Health System, Cardiovascular Research Center, Brazil
- Responsible party
- Sponsor
- Investigators
- Eberhard Grube, MD, Principal investigator, Universitats Klinikum BonnKimberlie O'Connell, MBA, Study director, Mitralign, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852149
- Sponsor's protocol ID
- CLPR-005
- Status last verified
- Mar 2016
- First submitted
- 7 May 2013
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Nickenig G, Schueler R, Dager A, Martinez Clark P, Abizaid A, Siminiak T, Buszman P, Demkow M, Ebner A, Asch FM, Hammerstingl C. Treatment of Chronic Functional Mitral Valve Regurgitation With a Percutaneous Annuloplasty System. J Am Coll Cardiol. 2016 Jun 28;67(25):2927-36. doi: 10.1016/j.jacc.2016.03.591.
PubMed 27339489
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitralign Percutaneous Annuloplasty First in Man (FIM) Study
- ClinicalTrials.gov ID
- NCT01852149
- Acronym / sponsor ID
- CLPR-005
- Conditions
- Functional Mitral Regurgitation
- Keywords
- Mitral Valve Regurgitation, Coaptation, Mitral Valve Repair, Plication, Leaflet, Annulus, Mitral Annuloplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mitralign, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medstar Health Research Institute, The Cooper Health System, Cardiovascular Research Center, Brazil
- Study start
- Aug 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 May 2013 (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 study is to assess the safety and feasibility of the Mitralign Percutaneous Annuloplasty System in humans for the treatment of chronic functional mitral regurgitation. No formal test of hypothesis is proposed for this trial.
Detailed description
The primary objective of this study is to test the ability to safely perform mitral posterior annulus plication with the Mitralign System in eligible patients with chronic functional MR using an endovascular approach. Data obtained from this study, combined with extensive pre-clinical data, will provide important technical and early clinical outcome information that will drive the next phase of clinical investigation and potentially enhance the future design of the Mitralign Percutaneous Annuloplasty System. It is anticipated that the Mitralign System will one day provide physicians with a safe and effective alternative therapy for treating patients who are candidates for mitral valve repair and offer a primary therapy option for patients superior to current treatment modalities.
This is a single-arm, multi-center, prospective study designed to test the safety and feasibility of the MPAS to treat patients with chronic, functional MR by performing plication of the posterior mitral annulus.
Up to a total of 36 patients with chronic functional mitral regurgitation will be enrolled: 1.) Up to 16 patients (12 patients + 1 roll-in patient per site) will be enrolled in Phase I. Up to thirty-four (34) patients will be enrolled in Phase II (MITRALIGN ADVANTAGE). All patients will be followed for 24 months. Up to 5 sites in Europe and South America will participate.
Study procedures include implantation of the MPAS, Trans-Esophogeal Echo, Trans-Thoracic Echo, Blood test, 6-min walk, Quality of Life, Chest X-ray and ECG.
Descriptive Statistics will be conducted for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MPAS Implant | Experimental | Device: MPAS ImplantMPAS Implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient with chronic functional mitral regurgitation.
- Patient is greater than 18 years old.
- Documented symptoms of CHF - NYHA II-IV.
- Left ventricular ejection fraction between 30 and 60 percent.
- Acceptable candidate for cardiac surgery and/or blood transfusion.
Key exclusion criteria (34 listed)
- Patient with significant organic mitral valve pathology such as myxomatous degeneration, mitral valve prolapse or flail leaflets moderate or severe valve calcifications, ruptured papillary muscles or ruptured chordae tendinae.
- Previous mitral valve repair or mitral valve replacement.
- Patient with mitral stenosis.
- Patient with moderate or severe aortic stenosis and or moderate or severe aortic regurgitation.
- Patient with endocarditis.
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 |
|---|---|---|
| MPAS ImplantAlso: Bident, Plication, Mitral annuloplasty, annulusThe Mitralign System consists of a set of catheters that enable the physician to position and place sutures and anchors through the posterior (back) annulus of the mitral valve under the guidance of echocardiography and fluoroscopy. Once the anchored sutures are in place, the sutures are pulled together. When the valve leaflets are close together, the sutures are locked with at least one stainless steel lock. The Bident Translation Catheter allows implantation of two pairs of pledgets. Each pair of pledgets plicates the annulus and then the pledgets are locked together from the ventricular side with a lock. | Device | MPAS Implant |
Primary outcome
The primary study endpoint will assess acute safety defined as the incidence of Device-related NACE (net adverse clinical events which includes Device Related Mortality, MI, Cardiac Tamponade and stroke) at 30 days
Time frame: 30 Days post implant
The primary study endpoint will assess acute safety using a composite clinical endpoint of device-related net adverse cardiac events (NACE) at 30 days. The components of NACE are defined as the occurrence of device related mortality, myocardial infarction, cardiac tamponade, cardiac surgery or stroke in per protocol population
1 secondary outcome
Echocardiographic measures
Time frame: 6 Months
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 18 Mar 2016.
- Derived from this study: PubMed 27339489Nickenig G, Schueler R, Dager A, Martinez Clark P, Abizaid A, Siminiak T, Buszman P, Demkow M, Ebner A, Asch FM, Hammerstingl C. Treatment of Chronic Functional Mitral Valve Regurgitation With a Percutaneous Annuloplasty System. J Am Coll Cardiol. 2016 Jun 28;67(25):2927-36. doi: 10.1016/j.jacc.2016.03.591.
- Sponsor websiteLink provided by the sponsor.
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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.
Eberhard Grube, MD principal investigator
Universitats Klinikum Bonn
Kimberlie O'Connell, MBA study director
Mitralign, Inc.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MPAS Implant in people with Functional Mitral Regurgitation, run by Mitralign, Inc. at 5 sites in 3 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 10 inclusion and 34 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 18 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 5 sites in Germany, Brazil, 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 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?
The primary study endpoint will assess acute safety defined as the incidence of Device-related NACE (net adverse clinical events which includes Device Related Mortality, MI, Cardiac Tamponade and stroke) at 30 days (time frame: 30 Days post implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01852149, which also lists 1 linked publication.
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 18 Mar 2016.