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

Primary Purpose

Mitral Valve Prolapse

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Prolapse focused on measuring Mitral Valve Prolapse, Mitral Valve Disease, Mitral Valve Regurgitation, Mitral Valve Insufficiency, Mitral Valve Incompetence, Percutaneous Mitral Valve Repair, Posterior leaflet prolapse, Mitral valve degeneration

Eligibility Criteria

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

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).

Sites / Locations

  • Papworth Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intevention-PMVr Procedure

Arm Description

Outcomes

Primary Outcome Measures

Device and Procedural Success
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.

Secondary Outcome Measures

Quantification of SAEs reported that are unique to the investigational procedure
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.

Full Information

First Posted
December 6, 2011
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01500148
Brief Title
St. Jude Medical Percutaneous Mitral Valve Repair Study
Acronym
SJM PMVr
Official Title
Clinical Assessment of the St. Jude Medical (SJM) Percutaneous Mitral Valve Repair (PMVr) Device Concept
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Subjects will be followed-up through 6 weeks post implantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Prolapse
Keywords
Mitral Valve Prolapse, Mitral Valve Disease, Mitral Valve Regurgitation, Mitral Valve Insufficiency, Mitral Valve Incompetence, Percutaneous Mitral Valve Repair, Posterior leaflet prolapse, Mitral valve degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intevention-PMVr Procedure
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)
Intervention Description
A maximum of ten (10) subjects will receive a percutaneous mitral valve clip procedure.
Primary Outcome Measure Information:
Title
Device and Procedural Success
Description
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.
Time Frame
During the investigational procedure
Secondary Outcome Measure Information:
Title
Quantification of SAEs reported that are unique to the investigational procedure
Description
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.
Time Frame
Through 6 weeks post-implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Papworth Hospital
City
Cambridge
Country
United Kingdom

12. IPD Sharing Statement

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St. Jude Medical Percutaneous Mitral Valve Repair Study

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