HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve

Mitral Regurgitation Clinical Trial

— HighFLO  

Official title:

HighLife TSMVR Feasibility Study of the Open Cell CLARITY Valve in Patients With Moderate-severe or Severe MR, High Surgical Risk and With a High Risk for Left Ventricular Outflow Tract Obstruction (LVOTO)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04888247
• Other study ID #: HL-2021-01
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: February 1, 2030

Study information

• Verified date: November 2023
• Source: HighLife SAS
• Contact: Luc Verhees
• Phone: +31 6 4270 2457
• Email: lverhees[@]highlifemed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system

Description:

Study to assess the feasibility, safety, and performance of the HighLife CLARITY TSMV, and its deliver systems, in NYHA Class ≥ II-IV patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment according to the local multidisciplinary Heart Team decision, and who are at high risk for potential LVOT obstruction(LVOTO).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 1, 2030
• Est. primary completion date: December 1, 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 for at least one month, as reviewed and confirmed by the local multidisciplinary Heart Team

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

8. Patients with a high risk for LVOTO

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:
• CLARITY
Trans-septal mitral valve replacement

Locations

Country	Name	City	State
Australia	Wesley Hospital	Auchenflower
Australia	Mount Hospital	Perth
Australia	Macquarie University Hospital	Sydney
Belgium	AZ St. Jan - Brugge	Brugge
Belgium	UZ Leuven	Leuven
France	CHU Lille	Lille
France	Centre Hospitalo - Univ de Nantes	Nantes
France	CHU de Rennes	Rennes
France	Cliniue Pasteur	Toulouse
Germany	Deutsches Herzzentrum Munchen	Munich
Germany	University Hospital Ulm	Ulm
Poland	Medical University of Silesia	Katowice
Poland	Medical University of Warsaw	Warsaw
United Kingdom	Brighton and Sussex University Hospital	Brighton

Sponsors (1)

Lead Sponsor	Collaborator
HighLife SAS

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of subjects meeting Technical Success	Successful vascular access, delivery and retrieval of the HighLife delivery systems; Deployment and correct positioning of the HighLife 28mm CLARITY TSMV; Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure. Any emergency surgery or re-intervention that occurs after the patient exits the procedure room/cath lab in stable condition will be captured as an AE/SAE; Successful vascular access, delivery and retrieval of the HighLife delivery systems; Deployment and correct positioning of the HighLife 28mm CLARITY TSMV; Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure. Any emergency surgery or re-intervention that occurs after the patient exits the procedure room/cath lab in stable condition will be captured as an AE/SAE	24 hours