Recruiting

HighLife

Sponsor:

HighLife SAS

Code:

NCT04029337

Conditions

Mitral Regurgitation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcatheter Mitral Valve Replacement

Study Details

Brief summary:

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

Study ID

NCT04029337

Start date

Jul 14, 2020

Status verified date

Mar, 2025

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transcatheter Mitral Valve Replacement

HighLife TMVR System is a novel and innovative approach developed as an alternative treatment for severe MR when medical treatment is maximal and surgical interventions not possible or at high risk. The HighLife TMVR system is composed of a Transcatheter Mitral Valve (TMV), a sub-annular implant (SAI), and their delivery systems and loading tools.

Interventions

Transcatheter Mitral Valve Replacement

Minimally invasive transcatheter mitral valve implantation using the HighLife™ TMVR system

Primary outcome measure

  • Freedom of major adverse events [ Time Frame: at 30 days post procedure ]
  • Continued intended performance of the HighLife™ bioprosthesis [ Time Frame: at 30 days post procedure ]

Central Contacts and Locations

Locations

Tucson Medical Center

Recruiting

Tucson, Arizona, United States, 85712

Contacts

Thomas Waggoner, MD

+1 520-838-3540Thomas Waggoner <twaggoner.med@gmail.com>

Los Robles Regional Medical Center

Recruiting

Los Angeles, California, United States, 91360

Contacts

Saibal Kar, MD

(805) 497-2727saibalkar60@gmail.com

Principal Investigator:

Saibal Kar, MD

Piedmont Heart

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Pradeep Yadav, MD

(404) 605-5000pradeep.yadav@piedmont.org

Principal Investigator:

Pradeep Yadav, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Pinank Shah, MD

+1 857-307-4000pbshah@bwh.harvard.edu

Minneapolis Heart

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Paul Sorajja, MD

(612) 863-3900paul.sorajja@allina.com

Principal Investigator:

Paul Sorajja, MD

Montefiore Medical Center

Recruiting

New York, New York, United States, 10467

Contacts

Azeem Latib, MD

(718) 920-4321mlatib@montefiore.org

Principal Investigator:

Azim Latib, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Daniel Steinberg, MD

(843) 792-1414steinbe@musc.edu

Principal Investigator:

Daniel Steinberg, MD

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Sachin Goel, MD

(713) 790-3311ssgoel@houstonmethodist.org

Principal Investigator:

Sachin Goel, MD

More Information

Sponsor

HighLife SAS

Last update posted

Mar 17, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by HighLife SAS on 2025-03-17.