St. Jude Medical Percutaneous Mitral Valve Repair Study

NCT01500148 | Completed Phase 1

• 1 other identifier: 1101
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  During the investigational procedure

Secondary Outcomes (1)

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

  Through 6 weeks post-implantation

Study Arms (1)

Intevention-PMVr Procedure

EXPERIMENTAL

Device: PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)

Interventions

PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr) DEVICE

A maximum of ten (10) subjects will receive a percutaneous mitral valve clip procedure.

Intevention-PMVr Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Papworth Hospital

Cambridge, United Kingdom

Location

MeSH Terms

Conditions

Mitral Valve Prolapse; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Prolapse; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: December 28, 2011
• Study Start: December 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

GB (1)