NCT01740583

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
4 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

4.2 years

First QC Date

November 30, 2012

Last Update Submit

October 13, 2016

Conditions

Mitral Valve Regurgitation

Keywords

mitral valve, regurgitation, annuloplasty

Outcome Measures

Primary Outcomes (1)

  • 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

    within 30 days post procedure

Secondary Outcomes (1)

  • Echocardiographic Outcomes

    at 6 months

Study Arms (1)

annuloplasty

EXPERIMENTAL

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

Device: percutaneous annuloplasty

Interventions

percutaneous annuloplastyDEVICE

plication of the mitral valve annulus

annuloplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Clinica CardioVID

Medellín, Antioquia, Colombia

Location

Antonio Dager, MD

Valle Del Cauca, Cali, Colombia

Location

Bordeaux Heart University Hospital

Bordeaux-Pessac, 33604, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Sanatorio Italiano

Asunción, Paraguay

Location

American Heart of Poland S.A.

Bielsko-Biala, 43-316, Poland

Location

Centrum Medyczne HZP

Poznan, 61-485, Poland

Location

Instytutem Kardiologii

Warsaw, 04-628, Poland

Location

MeSH Terms

Conditions

Mitral Valve InsufficiencyGastroesophageal Reflux

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Adrian Ebner, M.D.

    Sanatorio Italiano (The Italian Hospital)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2012

First Posted

December 4, 2012

Study Start

November 1, 2012

Primary Completion

January 1, 2017

Study Completion

November 1, 2017

Last Updated

October 17, 2016

Record last verified: 2016-10

Locations

CO(2)FR(2)PA(1)PL(3)