NCT04029337 An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
| NCT ID | NCT04029337 |
| Status | Recruiting |
| Phase | — |
| Sponsor | HighLife SAS |
| Condition | Mitral Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2020-07-14 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2020-07-14 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT04029337 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mitral Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04029337 currently recruiting?
Yes, NCT04029337 is actively recruiting participants. Visit ClinicalTrials.gov or contact HighLife SAS to inquire about joining.
Where is the NCT04029337 trial being conducted?
This trial is being conducted at Tucson, United States, Los Angeles, United States, Atlanta, United States, Boston, United States and 6 additional locations.
Who is sponsoring the NCT04029337 clinical trial?
NCT04029337 is sponsored by HighLife SAS. The trial plans to enroll 30 participants.