RECRUITING

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

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Conditions

Mitral Regurgitation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-07-14
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04029337

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Severe mitral regurgitation
  3. * New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
  4. * Patient is under maximally tolerated GDMT (incl. CRT) for at least 3 months
  5. * Multidisciplinary Heart Team consensus that the patient is inoperable or at high-risk for surgical repair/replacement due to significant co-morbid conditions
  6. * Multidisciplinary Heart Team consensus that the patient is not a suitable candidate for other approved percutaneous repair therapy due to anatomical or medical conditions
  7. * Patient meets the anatomical criteria for HighLife valve sizing as determined by CT and TEE
  1. * Mitral stenosis
  2. * Rheumatic valve disease
  3. * Severe calcifications of the mitral annulus and/or mitral leaflets
  4. * Prior surgical or interventional treatment of the mitral valve
  5. * Unsuitable anatomy for the transapical access
  6. * Unsuitable anatomy of the aorta and ilio-femoral vessels for the transfemoral access
  7. * Untreated clinically significant coronary artery disease requiring revascularization
  8. * LVEF \< 30%
  9. * LVEDD \> 70mm
  10. * Echocardiographic evidence of intracardiac mass, thrombus or vegetation
  11. * Hypertrophic Obstructive Cardiomyopathy (HOCM)
  12. * Any surgical or interventional procedure (including PCI) done in the past 30 days prior to procedure

Contacts and Locations

Study Locations (Sites)

Tucson Medical Center
Tucson, Arizona, 85712
United States
Los Robles Regional Medical Center
Los Angeles, California, 91360
United States
Piedmont Heart
Atlanta, Georgia, 30309
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Minneapolis Heart
Minneapolis, Minnesota, 55407
United States
Montefiore Medical Center
New York, New York, 10467
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
Chippenham Hospital Richmond
Richmond, Virginia, 23225
United States

Collaborators and Investigators

Sponsor: HighLife SAS

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 Registration Dates

Study Start Date2020-07-14
Study Completion Date2027-12

Study Record Updates

Study Start Date2020-07-14
Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

  • Mitral Regurgitation