Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04888247




Registration number
NCT04888247
Ethics application status
Date submitted
4/05/2021
Date registered
17/05/2021
Date last updated
29/11/2023

Titles & IDs
Public title
HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve
Scientific 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)
Secondary ID [1] 0 0
HL-2021-01
Universal Trial Number (UTN)
Trial acronym
HighFLO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mitral Regurgitation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - CLARITY

Experimental: Treatment - Trans-septal mitral valve replacement


Treatment: Devices: CLARITY
Trans-septal mitral valve replacement
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of subjects meeting Technical Success
Timepoint [1] 0 0
24 hours

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

-

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2030
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Wesley Hospital - Auchenflower
Recruitment hospital [2] 0 0
Mount Hospital - Perth
Recruitment hospital [3] 0 0
Macquarie University Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Auchenflower
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brugge
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
France
State/province [3] 0 0
Lille
Country [4] 0 0
France
State/province [4] 0 0
Nantes
Country [5] 0 0
France
State/province [5] 0 0
Rennes
Country [6] 0 0
France
State/province [6] 0 0
Toulouse
Country [7] 0 0
Germany
State/province [7] 0 0
Munich
Country [8] 0 0
Germany
State/province [8] 0 0
Ulm
Country [9] 0 0
Poland
State/province [9] 0 0
Katowice
Country [10] 0 0
Poland
State/province [10] 0 0
Warsaw
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Brighton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
HighLife SAS
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system
Trial website
https://clinicaltrials.gov/ct2/show/NCT04888247
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Luc Verhees
Address 0 0
Country 0 0
Phone 0 0
+31 6 4270 2457
Fax 0 0
Email 0 0
lverhees@highlifemed.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04888247