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Trial record 2 of 3 for:    LIBERTY | ( Map: Paraguay )

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

Tracking Information
First Submitted Date  ICMJE November 30, 2012
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date October 17, 2016
Study Start Date  ICMJE November 2012
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01740583 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
Echocardiographic Outcomes [ Time Frame: at 6 months ]
Freedom from an increase in ventricular diameter
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: November 30, 2012)
Clinical Outcomes [ Time Frame: 6 months ]
All-cause mortality, myocardial infarction, cardiac tamponade, stroke, NYHA Classification, 6 Minute Walk Test (distance), Quality of Life (Minnesota Living with Heart Failure Questionnaire), rehospitalization for congestive heart failure and/or mitral valve-related surgery or intervention, mitral regurgitation grade, left ventricular volumes and diameters and other echocardiographic measures.
Descriptive Information
Brief Title  ICMJE Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation
Official Title  ICMJE A Feasibility Study of the Mitralign Annuloplasty System for the Treatment of Chronic Functional Mitral Valve Regurgitation
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mitral Valve Regurgitation
Intervention  ICMJE Device: percutaneous annuloplasty
plication of the mitral valve annulus
Study Arms  ICMJE Experimental: annuloplasty
All patients will receive treatment with the Mitralign Percutaneous Annuloplasty System (MPAS).
Intervention: Device: percutaneous annuloplasty
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 30, 2012)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2017
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Paraguay,   Colombia,   France,   Poland
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01740583
Other Study ID Numbers  ICMJE CLPR-007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mitralign, Inc.
Study Sponsor  ICMJE Mitralign, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adrian Ebner, M.D. Sanatorio Italiano (The Italian Hospital)
PRS Account Mitralign, Inc.
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP