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Study identifier: NCT04029363 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Mitral Regurgitation  ·  Sponsor: HighLife SAS

PhaseNA
Planned participants120
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Martin Rothman, MD  ·  +1 707 2177167  ·  MRothman@highlifemed.com

Always discuss trial participation with your own doctor first.

Locations (50)

St. Vincent's Hospital - SydneyDarlinghurst, New South Wales, AustraliaRecruiting
John Hunter HospitalNewcastle, New South Wales, AustraliaRecruiting
Macquarie University HospitalSydney, New South Wales, AustraliaWithdrawn
The Wesley HospitalAuchenflower, Queensland, AustraliaRecruiting
St. Andrew's HospitalAdelaide, AustraliaRecruiting
Princess Alexandra HospitalBrisbane, AustraliaRecruiting
Warringal HospitalHeidelberg, AustraliaTerminated
The Alfred HospitalMelbourne, AustraliaRecruiting
John Hunter HospitalNewcastle, AustraliaRecruiting
Mount HospitalPerth, AustraliaRecruiting
North Shore Private HospitalSydney, AustraliaRecruiting
ZNA MiddelheimAntwerp, BelgiumRecruiting

+ 38 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT04029363