Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation (ALIGN)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01740583 |
Recruitment Status : Unknown
Verified October 2016 by Mitralign, Inc..
Recruitment status was: Active, not recruiting
First Posted : December 4, 2012
Last Update Posted : October 17, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mitral Valve Regurgitation | Device: percutaneous annuloplasty | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Feasibility Study of the Mitralign Annuloplasty System for the Treatment of Chronic Functional Mitral Valve Regurgitation |
Study Start Date : | November 2012 |
Estimated Primary Completion Date : | January 2017 |
Estimated Study Completion Date : | November 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: annuloplasty
All patients will receive treatment with the Mitralign Percutaneous Annuloplasty System (MPAS).
|
Device: percutaneous annuloplasty
plication of the mitral valve annulus |
- 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
- Echocardiographic Outcomes [ Time Frame: at 6 months ]Freedom from an increase in ventricular diameter

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740583
Colombia | |
Clinica CardioVID | |
Medellin, Antioquia, Colombia | |
Antonio Dager, MD | |
Valle del Cauca, Cali, Colombia | |
France | |
Bordeaux Heart University Hospital | |
Bordeaux-Pessac, France, 33604 | |
Clinique Pasteur | |
Toulouse, France, 31076 | |
Paraguay | |
Sanatorio Italiano | |
Asuncion, Paraguay | |
Poland | |
American Heart of Poland S.A. | |
Bielsko-Biala, Poland, 43-316 | |
Centrum Medyczne HZP | |
Poznan, Poland, 61-485 | |
Instytutem Kardiologii | |
Warsaw, Poland, 04-628 |
Principal Investigator: | Adrian Ebner, M.D. | Sanatorio Italiano (The Italian Hospital) |
Responsible Party: | Mitralign, Inc. |
ClinicalTrials.gov Identifier: | NCT01740583 History of Changes |
Other Study ID Numbers: |
CLPR-007 |
First Posted: | December 4, 2012 Key Record Dates |
Last Update Posted: | October 17, 2016 |
Last Verified: | October 2016 |
mitral valve, regurgitation, annuloplasty |
Mitral Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases |