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

HighLife SAS · NCT04029337

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
30
US sites recruiting
8
Study start
July 14, 2020
Record last updated
March 17, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Transcatheter Mitral Valve Replacement

Conditions: Mitral Regurgitation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion 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

Main Exclusion Criteria

  • 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

Recruiting US locations

  • Tucson Medical Center

    Tucson, AZ 85712

    Site contact: Thomas Waggoner, MD · +1 520-838-3540 · Thomas Waggoner <twaggoner.med@gmail.com>

  • Los Robles Regional Medical Center

    Los Angeles, CA 91360

    Site contact: Saibal Kar, MD · (805) 497-2727 · saibalkar60@gmail.com

  • Piedmont Heart

    Atlanta, GA 30309

    Site contact: Pradeep Yadav, MD · (404) 605-5000 · pradeep.yadav@piedmont.org

  • Brigham and Women's Hospital

    Boston, MA 02115

    Site contact: Pinank Shah, MD · +1 857-307-4000 · pbshah@bwh.harvard.edu

  • Minneapolis Heart

    Minneapolis, MN 55407

    Site contact: Paul Sorajja, MD · (612) 863-3900 · paul.sorajja@allina.com

  • Montefiore Medical Center

    New York, NY 10467

    Site contact: Azeem Latib, MD · (718) 920-4321 · mlatib@montefiore.org

  • Medical University of South Carolina

    Charleston, SC 29425

    Site contact: Daniel Steinberg, MD · (843) 792-1414 · steinbe@musc.edu

  • Houston Methodist Hospital

    Houston, TX 77030

    Site contact: Sachin Goel, MD · (713) 790-3311 · ssgoel@houstonmethodist.org

An Early Feasibility Study of the HighLife 28mm Trans-Septal… (NCT04029337) | Bored Studies