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Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation (ALIGN)

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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
Sponsor:
Information provided by (Responsible Party):
Mitralign, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Mitral Valve Regurgitation Device: percutaneous annuloplasty Not Applicable

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
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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
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Echocardiographic Outcomes [ Time Frame: at 6 months ]
    Freedom from an increase in ventricular diameter


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Mitralign, Inc.
Investigators
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Principal Investigator: Adrian Ebner, M.D. Sanatorio Italiano (The Italian Hospital)
More Information
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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
Keywords provided by Mitralign, Inc.:
mitral valve, regurgitation, annuloplasty
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases