St. Jude Medical Percutaneous Mitral Valve Repair Study (SJM PMVr)

February 1, 2019 updated by: Abbott Medical Devices

Clinical Assessment of the St. Jude Medical (SJM) Percutaneous Mitral Valve Repair (PMVr) Device Concept

The purpose of this proof-of-concept study is to assess the relative safety and feasibility of the SJM Percutaneous Mitral Valve Repair (PMVr) Device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will be followed-up through 6 weeks post implantation.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject has symptomatic or asymptomatic moderate (2+) or severe (3-4+) mitral regurgitation.
  • Subject has an ejection fraction (EF) ≥ 30%.
  • Subject is of legal age (≥18 years old).
  • Subject is planned to undergo surgical repair or replacement of the mitral valve for symptomatic or asymptomatic posterior leaflet mitral prolapse.

Exclusion Criteria:

  • Subject requires a complex mitral valve repair or has isolated anterior prolapse.
  • Subject has mitral valve stenosis in which the annulus opening is <10mm. Subject has valve disease other than mitral which requires surgical intervention.
  • Subject requires a concomitant procedure.
  • Subject has a pre-existing prosthetic valve in any position.
  • Subject had stenting or PCI within 6 months before the planned procedure, or is anticipated to require stenting or PCI within 6 months post-procedure.
  • Subject has calcification of the mitral leaflets or annulus which in the medical opinion of the surgical investigator would limit repair and /or implantation of the investigational device.
  • Subject has renal insufficiency or is on chronic dialysis.
  • Subject has had a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months.
  • Subject has a history of endocarditis or has active endocarditis.
  • Subject has a history of autoimmune disease.
  • Subject has significant known carotid artery disease.
  • Subject has an aorto-mitral angle of <110 degrees.
  • Subject has hypertrophic obstructive cardiomyopathy (HOCM's Disease).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intevention-PMVr Procedure
Device: PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)
A maximum of ten (10) subjects will receive a percutaneous mitral valve clip procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device and Procedural Success
Time Frame: During the investigational procedure

The primary objective is to evaluate the technical feasibility and acute device deployment characteristics of the SJM PMVr Device.

Technical feasibility and deployment characteristics will be defined as:

  • The ability of the delivery system to access the mitral valve
  • The ability of the device to capture mitral valve (MV) leaflet tissue
  • Ability to plicate MV leaflet tissue
  • The clip is able to be deployed in MV leaflet tissue
  • The delivery system is able to be removed.
During the investigational procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of SAEs reported that are unique to the investigational procedure
Time Frame: Through 6 weeks post-implantation
The secondary objective is to evaluate safety of the SJM PMVr device by summarizing SAEs unique to accessing the valve, placing the clip, and removing the delivery system.
Through 6 weeks post-implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

December 6, 2011

First Submitted That Met QC Criteria

December 27, 2011

First Posted (Estimate)

December 28, 2011

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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