Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk

Recruiting now · Not applicable

Conditions studied: Mitral Regurgitation

In brief

to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.

Key facts

Study ID

NCT04029363

Run by

HighLife SAS

People needed

120

Starts

2019-05-28

Expected to finish

2031-12-15

Last updated by the study team

2025-09-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Age ≥ 18 years 2. Moderate-severe or severe mitral regurgitation (≥ 3+) 3. Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV 4. Patient is under guideline directed medical therapy, as reviewed and confirmed by the local multidisciplinary Heart Team, for at least one month 5. Patient is high-risk for open-heart surgery based on the assessment of the multidisciplinary Heart Team using standard scoring systems and consideration of co-morbidities, frailty, and disability 6. Patient meets the anatomical criteria for HighLife valve 7. Patient is willing to participate in the study and provides signed informed consent

You may not qualify if…

• Any stroke/TIA within 30 days
• Severe symptomatic carotid stenosis (> 70% by non-invasive imaging)
• Active infections requiring antibiotic therapy
• Active ulcer or gastro-intestinal bleeding in the past 3 months
• History of bleeding diathesis, coagulopathy or refusal of future blood transfusion
• Patients in whom TEE is not feasible
• Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months.
• Patient is unable to comply with the follow-up schedule and assessments
• Participation in another clinical investigation at the time of inclusion
• Patient has known allergies to the device components or contrast medium
• Patient cannot tolerate anticoagulation or antiplatelet therapy
• Patients with a life expectancy of less than 12 months due to non-cardiac conditions
• Patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 3 months

Where it is running

• St. Vincent's Hospital - Sydney — Darlinghurst, New South Wales, Australia (enrolling)
• John Hunter Hospital — Newcastle, New South Wales, Australia (enrolling)
• Deutsches Herzzentrum Munchen — Munich, Germany (enrolling)
• University Hospital Ulm — Ulm, Germany (enrolling)
• Medical University of Gdansk — Gdansk, Poland (enrolling)
• Medical University of Silesia Hospital — Katowice, Poland (enrolling)
• Medical University of Warsaw — Warsaw, Poland (enrolling)
• Institute of Cardiology — Warsaw, Poland (enrolling)
• National Heart Center Singapore — Singapore, Singapore (enrolling)
• Royal Victoria Hospital — Belfast, United Kingdom (enrolling)
• Brighton and Sussex University Hospital — Brighton, United Kingdom (enrolling)
• Royal Infirmary of Edinburgh — Edinburgh, United Kingdom (enrolling)
• Guy's and St. Thomas' NHS Foundation Trust - St. Thomas Hospital — London, United Kingdom (enrolling)
• The Wesley Hospital — Auchenflower, Queensland, Australia (enrolling)
• St. Andrew's Hospital — Adelaide, Australia (enrolling)
• Princess Alexandra Hospital — Brisbane, Australia (enrolling)
• The Alfred Hospital — Melbourne, Australia (enrolling)
• John Hunter Hospital — Newcastle, Australia (enrolling)
• Mount Hospital — Perth, Australia (enrolling)
• North Shore Private Hospital — Sydney, Australia (enrolling)
• ZNA Middelheim — Antwerp, Belgium (enrolling)
• AZ Sint-Jan — Bruges, Belgium (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• Rangueil University Hospital — Toulouse, Toulouse, France (enrolling)
• CHU Lille — Lille, France (enrolling)

Full record on ClinicalTrials.gov

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