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Mitralign Percutaneous Annuloplasty First in Man Study

NCT01852149 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2016-03-18

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and feasibility of the Mitralign Percutaneous Annuloplasty System in humans for the treatment of chronic functional mitral regurgitation. No formal test of hypothesis is proposed for this trial.

Conditions

  • Functional Mitral Regurgitation

Interventions

DEVICE

MPAS Implant

The Mitralign System consists of a set of catheters that enable the physician to position and place sutures and anchors through the posterior (back) annulus of the mitral valve under the guidance of echocardiography and fluoroscopy. Once the anchored sutures are in place, the sutures are pulled together. When the valve leaflets are close together, the sutures are locked with at least one stainless steel lock. The Bident Translation Catheter allows implantation of two pairs of pledgets. Each pair of pledgets plicates the annulus and then the pledgets are locked together from the ventricular side with a lock.

Sponsors & Collaborators

  • Medstar Health Research Institute

    collaborator OTHER

  • The Cooper Health System

    collaborator OTHER

  • Cardiovascular Research Center, Brazil

    collaborator OTHER

  • Mitralign, Inc.

    lead INDUSTRY

Principal Investigators

  • Eberhard Grube, MD · Universitats Klinikum Bonn

  • Kimberlie O'Connell, MBA · Mitralign, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2014-03-31
Completion
2015-09-30

Countries

  • Brazil
  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01852149 on ClinicalTrials.gov