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

Mitral Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04029363
• Other study ID #: HL-2018-01-TS Expanded EU/AU
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2019
• Est. completion date: June 15, 2029

Study information

• Verified date: November 2023
• Source: HighLife SAS
• Contact: Martin Rothman, MD
• Phone: +1 707 2177167
• Email: MRothman[@]highlifemed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 15, 2029
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• HighLife Transcatheter Mitral Valve Replacement
Transcatheter Mitral Valve Replacement

Locations

Country	Name	City	State
Australia	St. Andrew's Hospital	Adelaide
Australia	The Wesley Hospital	Auchenflower	Queensland
Australia	St. Vincent's Hospital - Sydney	Darlinghurst	New South Wales
Australia	Warringal Hospital	Heidelberg
Australia	The Alfred Hospital	Melbourne
Australia	John Hunter Hospital	Newcastle	New South Wales
Australia	Mount Hospital	Perth
Australia	Macquarie University Hospital	Sydney	New South Wales
Australia	North Shore Private Hospital	Sydney
Belgium	ZNA Middelheim	Antwerp
Belgium	AZ Sint-Jan	Brugge
Belgium	UZ Leuven	Leuven
France	CHU Lille	Lille
France	Hopital Prive - Jacques Cartier	Massy
France	Centre Hospitalo-Universitaire de Nantes	Nantes
France	European Hospital George Pompidou	Paris
France	CHU Bordeaux	Pessac
France	CHU de Rennes	Rennes
France	Centr Cardiologiqque du Nord	St. Denis
France	Clinque Pasteur	Toulouse
France	Rangueil University Hospital	Toulouse
Germany	University Heart Center Freiburg - Bad Krozingen	Bad Krozingen
Germany	Universitaetsklinikum Bonn	Bonn
Germany	Heart Center, University Hospital Dresden	Dresden
Germany	Universitatsklink Hamburg-Eppendorf	Hamburg
Germany	University Hospital Heidelberg	Heidelberg
Germany	Herzentrum Leipzig	Leipzig
Germany	Deutsches Herzzentrum Munchen	Munich
Germany	University Medicine Dept of Cardiology	Rostock
Germany	University Hospital Ulm	Ulm
Poland	Medical University of Silesia Hospital	Katowice
Poland	University Hospital of Lord's Transfiguration	Poznan
Poland	Institute of Cardiology	Warsaw
Poland	Medical University of Warsaw	Warsaw
United Kingdom	Royal Victoria Hospital	Belfast
United Kingdom	Brighton and Sussex University Hospital	Brighton
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester
United Kingdom	Barts Heart Center	London
United Kingdom	Guy's and St. Thomas' NHS Foundation Trust - St. Thomas Hospital	London
United Kingdom	John Radcliffe	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
HighLife SAS	ICON plc

Countries where clinical trial is conducted

Australia,  Belgium,  France,  Germany,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Safety	Freedom from major adverse events	30 days