Evaluating a new transcatheter mitral valve for patients with severe mitral regurgitation
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
This study is testing a new heart valve to see if it can safely help high-risk patients with severe mitral regurgitation who can’t have regular surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | HighLife SAS Industry-sponsored |
| Locations | 50 sites (Darlinghurst, New South Wales and 49 other locations) |
| Trial ID | NCT04029363 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and effectiveness of the HighLife 28mm trans-septal mitral valve in patients suffering from moderate-severe or severe mitral regurgitation who are considered high-risk for traditional surgical interventions. Participants will be evaluated based on their functional class and must be under appropriate medical therapy prior to the procedure. The study will involve a multidisciplinary Heart Team to determine eligibility and monitor patient outcomes following the valve replacement procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with moderate-severe or severe mitral regurgitation and high surgical risk.
Not a fit: Patients with recent strokes, severe carotid stenosis, active infections, or significant bleeding disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could provide a less invasive treatment option for patients with severe mitral regurgitation who are at high surgical risk.
How similar studies have performed: Other studies have shown promise with transcatheter mitral valve approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
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Where this trial is running
Darlinghurst, New South Wales and 49 other locations
- St. Vincent's Hospital - Sydney — Darlinghurst, New South Wales, Australia (Recruiting)
- John Hunter Hospital — Newcastle, New South Wales, Australia (Recruiting)
- Macquarie University Hospital — Sydney, New South Wales, Australia (Withdrawn)
- The Wesley Hospital — Auchenflower, Queensland, Australia (Recruiting)
- St. Andrew's Hospital — Adelaide, Australia (Recruiting)
- Princess Alexandra Hospital — Brisbane, Australia (Recruiting)
- Warringal Hospital — Heidelberg, Australia (Terminated)
- The Alfred Hospital — Melbourne, Australia (Recruiting)
- John Hunter Hospital — Newcastle, Australia (Recruiting)
- Mount Hospital — Perth, Australia (Recruiting)
- North Shore Private Hospital — Sydney, Australia (Recruiting)
- ZNA Middelheim — Antwerp, Belgium (Recruiting)
- AZ Sint-Jan — Bruges, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- Rangueil University Hospital — Toulouse, Toulouse, France (Recruiting)
- CHU Lille — Lille, France (Recruiting)
- Medipole Lyon-Villeurbanne — Lyon, France (Recruiting)
- Hopital Prive - Jacques Cartier — Massy, France (Recruiting)
- Centre Hospitalo-Universitaire de Nantes — Nantes, France (Recruiting)
- European Hospital George Pompidou — Paris, France (Terminated)
- CHU Bordeaux — Pessac, France (Recruiting)
- CHU de Rennes — Rennes, France (Recruiting)
- Centr Cardiologiqque du Nord — Saint-Denis, France (Recruiting)
- CHRU Strasbourg — Strasbourg, France (Recruiting)
- Clinque Pasteur — Toulouse, France (Recruiting)
- Rangueil University Hospital — Toulouse, France (Recruiting)
- University Heart Center Freiburg - Bad Krozingen — Bad Krozingen, Germany (Terminated)
- Universitaetsklinikum Bonn — Bonn, Germany (Recruiting)
- Heart Center, University Hospital Dresden — Dresden, Germany (Recruiting)
- Universitatsklink Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
- Mediinisches Versorgungszentrum — Hamburg, Germany (Recruiting)
- University Hospital Heidelberg — Heidelberg, Germany (Terminated)
- Herzentrum Leipzig — Leipzig, Germany (Recruiting)
- Deutsches Herzzentrum Munchen — Munich, Germany (Recruiting)
- University Medicine Dept of Cardiology — Rostock, Germany (Terminated)
- University Hospital Ulm — Ulm, Germany (Recruiting)
- Medical University of Gdansk — Gdansk, Poland (Recruiting)
- Medical University of Silesia Hospital — Katowice, Poland (Recruiting)
- University Hospital of Lord's Transfiguration — Poznan, Poland (Terminated)
- Medical University of Warsaw — Warsaw, Poland (Recruiting)
- Institute of Cardiology — Warsaw, Poland (Recruiting)
- National Heart Center Singapore — Singapore, Singapore (Recruiting)
- Royal Victoria Hospital — Belfast, United Kingdom (Recruiting)
- Brighton and Sussex University Hospital — Brighton, United Kingdom (Recruiting)
- Royal Infirmary of Edinburgh — Edinburgh, United Kingdom (Recruiting)
- Leeds Teaching Hospitals NHS Trust — Leeds, United Kingdom (Terminated)
- University Hospitals of Leicester NHS Trust — Leicester, United Kingdom (Terminated)
- Guy's and St. Thomas' NHS Foundation Trust - St. Thomas Hospital — London, United Kingdom (Recruiting)
- Barts Heart Center — London, United Kingdom (Terminated)
- John Radcliffe — Oxford, United Kingdom (Terminated)
Study contacts
- Study coordinator: Martin Rothman, MD
- Email: MRothman@highlifemed.com
- Phone: +1 707 2177167
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.