NCT04029363 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
| NCT ID | NCT04029363 |
| Status | Recruiting |
| Phase | — |
| Sponsor | HighLife SAS |
| Condition | Mitral Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2019-05-28 |
| Primary Completion | 2026-12-15 |
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 120 participants in total. It began in 2019-05-28 with a primary completion date of 2026-12-15.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: 1. Any stroke/TIA within 30 days 2. Severe symptomatic carotid stenosis (\> 70% by non-invasive imaging) 3. Active infections requiring antibiotic therapy 4. Active ulcer or gastro-intestinal bleeding in the past 3 months 5. History of bleeding diathesis, coagulopathy or refusal of future blood transfusion 6. Patients in whom TEE is not feasible 7. Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months. 8. Patient is unable to comply with the follow-up schedule and assessments 9. Participation in another clinical investigation at the time of inclusion 10. Patient has known allergies to the device components or contrast medium 11. Patient cannot tolerate anticoagulation or antiplatelet therapy 12. Patients with a life expectancy of less than 12 months due to non-cardiac conditions 13. Patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 3 months \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04029363 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 NCT04029363 currently recruiting?
Yes, NCT04029363 is actively recruiting participants. Contact the research team at MRothman@highlifemed.com for enrollment information.
Where is the NCT04029363 trial being conducted?
This trial is being conducted at Darlinghurst, Australia, Newcastle, Australia, Sydney, Australia, Auchenflower, Australia and 11 additional locations.
Who is sponsoring the NCT04029363 clinical trial?
NCT04029363 is sponsored by HighLife SAS. The trial plans to enroll 120 participants.