Mitral Valve RegurgitationALIGNNCT01740583
Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation
A study testing percutaneous annuloplasty in people with Mitral Valve Regurgitation, run by Mitralign, Inc. at 8 sites in 4 countries.
Trial summary
The purpose of this study is to test the safety and device performance of the Mitralign system ("MPAS") to treat functional mitral valve regurgitation. 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?
- percutaneous annuloplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Nov 2012to Nov 2017
- 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
- NYHA II-IV
- Structurally normal mitral valve
- At least Grade 2 mitral regurgitation
- Left ventricular ejection fraction not less than 20% and not greater than 45%
- Left ventricular end diastolic diameter not less than 5.0 cm and not greater than 7.5 cm
Who cannot join
- Pregnant or lactating female
- Mitral stenosis
- Mod/severe aortic stenosis or regurgitation
- Mod/severe tricuspid stenosis or regurgitation
- Endocarditis
- Previous mitral valve repair or MV replacement
Show all 10Show fewer
- Bioprosthetic or mechanical aortic valve
- Known unstable angina or MI within 30 days prior to procedure
- CVA within past 6 months
- Known contraindications to blood transfusion, contrast dye, DAPT
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Poland3 sites
American Heart of Poland S.A.
Bielsko-Biala, 43-316
Centrum Medyczne HZP
Poznan, 61-485
Instytutem Kardiologii
Warsaw, 04-628
Colombia2 sites
Clinica CardioVID
Medellín, Antioquia
Antonio Dager, MD
Valle Del Cauca, Cali
France2 sites
Bordeaux Heart University Hospital
Bordeaux-Pessac, 33604
Clinique Pasteur
Toulouse, 31076
About this study
Official title: A Feasibility Study of the Mitralign Annuloplasty System for the Treatment of Chronic Functional Mitral Valve Regurgitation
The purpose of this study is to test the safety and device performance of the Mitralign system ("MPAS") to treat functional mitral valve regurgitation.
Read the detailed description
The ALIGN study is a single arm, prospective study. The objective of the study is to investigate the safety and performance of a catheter-based plication device intended to reduce the circumference of the dilated mitral valve. The study will enroll up to 50 subjects from up to 5 sites (Paraguay, Columbia, Dominican Republic, Brazil, and India) who will be followed for 36 months post index procedure. Enrollment is defined at the time the study device is inserted into the body and patients will be followed at 30 days, and Months 6, 12, 24 and 36 post index procedure.
- Conditions
- Mitral Valve Regurgitation
- Being tested
- percutaneous annuloplasty
- Keywords
- mitral valve, regurgitation, annuloplasty
- Medical subject headings
- Mitral Valve Insufficiency, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous annuloplastyDevice
plication of the mitral valve annulus
| Study group | Role | What they receive |
|---|---|---|
| annuloplasty | Experimental | All patients will receive treatment with the Mitralign Percutaneous Annuloplasty System (MPAS). Receives: Device: percutaneous annuloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Events (MAE)
MAE defined as occurrence of any of the following: Mitral valve-related surgery/intervention, myocardial infarction, cardiac tamponade, stroke, device and/or procedure-related death
Measured: within 30 days post procedure
Secondary outcomes (1)
Echocardiographic Outcomes
Freedom from an increase in ventricular diameter
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2017 (estimated)
- Study completionNov 2017 (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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mitralign, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian Ebner, M.D., Principal investigator, Sanatorio Italiano (The Italian Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740583
- Sponsor's protocol ID
- CLPR-007
- Acronym
- ALIGN
- Status last verified
- Oct 2016
- First submitted
- 30 Nov 2012
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of the Mitralign Annuloplasty System for the Treatment of Chronic Functional Mitral Valve Regurgitation
- ClinicalTrials.gov ID
- NCT01740583
- Acronym / sponsor ID
- ALIGN / CLPR-007
- Conditions
- Mitral Valve Regurgitation
- Keywords
- mitral valve, regurgitation, annuloplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mitralign, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 4 Dec 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 purpose of this study is to test the safety and device performance of the Mitralign system ("MPAS") to treat functional mitral valve regurgitation.
Detailed description
The ALIGN study is a single arm, prospective study. The objective of the study is to investigate the safety and performance of a catheter-based plication device intended to reduce the circumference of the dilated mitral valve. The study will enroll up to 50 subjects from up to 5 sites (Paraguay, Columbia, Dominican Republic, Brazil, and India) who will be followed for 36 months post index procedure. Enrollment is defined at the time the study device is inserted into the body and patients will be followed at 30 days, and Months 6, 12, 24 and 36 post index procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| annuloplasty | Experimental | Device: percutaneous annuloplastyAll patients will receive treatment with the Mitralign Percutaneous Annuloplasty System (MPAS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- NYHA II-IV
- Structurally normal mitral valve
- At least Grade 2 mitral regurgitation
- Left ventricular ejection fraction not less than 20% and not greater than 45%
- Left ventricular end diastolic diameter not less than 5.0 cm and not greater than 7.5 cm
Key exclusion criteria (10 listed)
- Pregnant or lactating female
- Mitral stenosis
- Mod/severe aortic stenosis or regurgitation
- Mod/severe tricuspid stenosis or regurgitation
- 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 |
|---|---|---|
| percutaneous annuloplastyplication of the mitral valve annulus | Device | annuloplasty |
Primary outcome
Major Adverse Events (MAE)
Time frame: within 30 days post procedure
MAE defined as occurrence of any of the following: Mitral valve-related surgery/intervention, myocardial infarction, cardiac tamponade, stroke, device and/or procedure-related death
1 secondary outcome
Echocardiographic Outcomes
Time frame: at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
Related trials for Mitral Valve Regurgitation
Recruiting
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
Mitral Regurgitation, Mitral Valve Disease
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
Not yet recruiting
Early Feasibility Study of the Capstan Medical TMVR System
Mitral Regurgitation (MR)
Not yet recruiting
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Valvular Heart Disease Patients, Aortic Stenosis
Active, not recruiting
Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve Repair
Mitral Regurgitation (MR)
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.
Adrian Ebner, M.D. principal investigator
Sanatorio Italiano (The Italian Hospital)
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous annuloplasty in people with Mitral Valve Regurgitation, run by Mitralign, Inc. at 8 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 5 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 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Poland, Colombia, France, Paraguay. 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?
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?
Major Adverse Events (MAE) (time frame: within 30 days post 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 17 Oct 2016; AzTrials last refreshed its copy on 6 Nov 2026.