An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

Description

Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment.

Conditions

Mitral Regurgitation

Talk to us

Study Overview

On this page

Study Details

Study overview

Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment.

An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

Condition
Mitral Regurgitation
Intervention / Treatment

-

Contacts and Locations

Tucson

Tucson Medical Center, Tucson, Arizona, United States, 85712

Los Angeles

Los Robles Regional Medical Center, Los Angeles, California, United States, 91360

Atlanta

Piedmont Heart, Atlanta, Georgia, United States, 30309

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Minneapolis

Minneapolis Heart, Minneapolis, Minnesota, United States, 55407

New York

Montefiore Medical Center, New York, New York, United States, 10467

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Charleston

Medical University of South Carolina, Charleston, South Carolina, United States, 29425

Houston

Houston Methodist Hospital, Houston, Texas, United States, 77030

Richmond

Chippenham Hospital Richmond, Richmond, Virginia, United States, 23225

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age ≥ 18 years
  • * Severe mitral regurgitation
  • * New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
  • * Patient is under maximally tolerated GDMT (incl. CRT) for at least 3 months
  • * Multidisciplinary Heart Team consensus that the patient is inoperable or at high-risk for surgical repair/replacement due to significant co-morbid conditions
  • * Multidisciplinary Heart Team consensus that the patient is not a suitable candidate for other approved percutaneous repair therapy due to anatomical or medical conditions
  • * Patient meets the anatomical criteria for HighLife valve sizing as determined by CT and TEE
  • * Mitral stenosis
  • * Rheumatic valve disease
  • * Severe calcifications of the mitral annulus and/or mitral leaflets
  • * Prior surgical or interventional treatment of the mitral valve
  • * Unsuitable anatomy for the transapical access
  • * Unsuitable anatomy of the aorta and ilio-femoral vessels for the transfemoral access
  • * Untreated clinically significant coronary artery disease requiring revascularization
  • * LVEF \< 30%
  • * LVEDD \> 70mm
  • * Echocardiographic evidence of intracardiac mass, thrombus or vegetation
  • * Hypertrophic Obstructive Cardiomyopathy (HOCM)
  • * Any surgical or interventional procedure (including PCI) done in the past 30 days prior to procedure

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

HighLife SAS,

Study Record Dates

2027-12