search
Back to results

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

Primary Purpose

Mitral Valve Regurgitation

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
percutaneous annuloplasty
Sponsored by
Mitralign, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Regurgitation focused on measuring mitral valve, regurgitation, annuloplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinica CardioVID
  • Antonio Dager, MD
  • Bordeaux Heart University Hospital
  • Clinique Pasteur
  • Sanatorio Italiano
  • American Heart of Poland S.A.
  • Centrum Medyczne HZP
  • Instytutem Kardiologii

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

annuloplasty

Arm Description

All patients will receive treatment with the Mitralign Percutaneous Annuloplasty System (MPAS).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Echocardiographic Outcomes
Freedom from an increase in ventricular diameter

Full Information

First Posted
November 30, 2012
Last Updated
October 13, 2016
Sponsor
Mitralign, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01740583
Brief Title
Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation
Acronym
ALIGN
Official Title
A Feasibility Study of the Mitralign Annuloplasty System for the Treatment of Chronic Functional Mitral Valve Regurgitation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitralign, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Regurgitation
Keywords
mitral valve, regurgitation, annuloplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
annuloplasty
Arm Type
Experimental
Arm Description
All patients will receive treatment with the Mitralign Percutaneous Annuloplasty System (MPAS).
Intervention Type
Device
Intervention Name(s)
percutaneous annuloplasty
Intervention Description
plication of the mitral valve annulus
Primary Outcome Measure Information:
Title
Major Adverse Events (MAE)
Description
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
Time Frame
within 30 days post procedure
Secondary Outcome Measure Information:
Title
Echocardiographic Outcomes
Description
Freedom from an increase in ventricular diameter
Time Frame
at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Ebner, M.D.
Organizational Affiliation
Sanatorio Italiano (The Italian Hospital)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica CardioVID
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Antonio Dager, MD
City
Valle del Cauca
State/Province
Cali
Country
Colombia
Facility Name
Bordeaux Heart University Hospital
City
Bordeaux-Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
Sanatorio Italiano
City
Asuncion
Country
Paraguay
Facility Name
American Heart of Poland S.A.
City
Bielsko-Biala
ZIP/Postal Code
43-316
Country
Poland
Facility Name
Centrum Medyczne HZP
City
Poznan
ZIP/Postal Code
61-485
Country
Poland
Facility Name
Instytutem Kardiologii
City
Warsaw
ZIP/Postal Code
04-628
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation

We'll reach out to this number within 24 hrs