Back to resultsHighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve (HighFLO)
Primary Purpose
Mitral Regurgitation
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CLARITY
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Regurgitation
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Moderate-severe or severe mitral regurgitation (≥ 3+)
- Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
- Patient is under guideline directed medical therapy for at least one month, as reviewed and confirmed by the local multidisciplinary Heart Team
- 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
- Patient meets the anatomical criteria for HighLife valve
- Patient is willing to participate in the study and provides signed informed consent
- Patients with a high risk for LVOTO
Exclusion Criteria:
- Any stroke/TIA within 30 days
- Severe symptomatic carotid stenosis (> 70% by non-invasive imaging)
- Active infections requiring antibiotic therapy
- Active ulcer or gastro-intestinal bleeding in the past 3 months
- History of bleeding diathesis, coagulopathy or refusal of future blood transfusion
- Patients in whom TEE is not feasible
- Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months.
- Patient is unable to comply with the follow-up schedule and assessments
- Participation in another clinical investigation at the time of inclusion
- Patient has known allergies to the device components or contrast medium
- Patient cannot tolerate anticoagulation or antiplatelet therapy
- Patients with a life expectancy of less than 12 months due to non-cardiac conditions
Patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 3 months
-
Sites / Locations
- Wesley HospitalRecruiting
- Mount HospitalRecruiting
- Macquarie University HospitalRecruiting
- AZ St. Jan - BruggeRecruiting
- UZ LeuvenRecruiting
- CHU de RennesRecruiting
- Cliniue PasteurRecruiting
- Deutsches Herzzentrum MunchenRecruiting
- University Hospital UlmRecruiting
- Medical University of Silesia
- Medical University of WarsawRecruiting
- Brighton and Sussex University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Trans-septal mitral valve replacement
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04888247
Brief Title
HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
January 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HighLife SAS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Regurgitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Trans-septal mitral valve replacement
Intervention Type
Device
Intervention Name(s)
CLARITY
Intervention Description
Trans-septal mitral valve replacement
Primary Outcome Measure Information:
Title
Rate of subjects meeting Technical Success
Description
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
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Moderate-severe or severe mitral regurgitation (≥ 3+)
Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
Patient is under guideline directed medical therapy for at least one month, as reviewed and confirmed by the local multidisciplinary Heart Team
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
Patient meets the anatomical criteria for HighLife valve
Patient is willing to participate in the study and provides signed informed consent
Patients with a high risk for LVOTO
Exclusion Criteria:
Any stroke/TIA within 30 days
Severe symptomatic carotid stenosis (> 70% by non-invasive imaging)
Active infections requiring antibiotic therapy
Active ulcer or gastro-intestinal bleeding in the past 3 months
History of bleeding diathesis, coagulopathy or refusal of future blood transfusion
Patients in whom TEE is not feasible
Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months.
Patient is unable to comply with the follow-up schedule and assessments
Participation in another clinical investigation at the time of inclusion
Patient has known allergies to the device components or contrast medium
Patient cannot tolerate anticoagulation or antiplatelet therapy
Patients with a life expectancy of less than 12 months due to non-cardiac conditions
Patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 3 months
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luc Verhees
Phone
+31 6 4270 2457
Email
lverhees@highlifemed.com
Facility Information:
Facility Name
Wesley Hospital
City
Auchenflower
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Camuglia, MD
First Name & Middle Initial & Last Name & Degree
Anthony Camuglia, MD
Facility Name
Mount Hospital
City
Perth
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Yeow, MD
Phone
+61 8 9400 6217
Email
wyeow@heartwest.com.au
First Name & Middle Initial & Last Name & Degree
Wen Yeow, MD
Facility Name
Macquarie University Hospital
City
Sydney
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Worthley, MD
First Name & Middle Initial & Last Name & Degree
Stephen Worthley, MD
Facility Name
AZ St. Jan - Brugge
City
Brugge
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan van der Heyden, MD
First Name & Middle Initial & Last Name & Degree
Jan van der Heyden, MD
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Dubois, MD
First Name & Middle Initial & Last Name & Degree
Christophe Dubois, MD
Facility Name
CHU de Rennes
City
Rennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Leurent, MD
First Name & Middle Initial & Last Name & Degree
Guillaume Leurent, MD
Facility Name
Cliniue Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didier Tchetche
Phone
+33562211699
Email
dtchetche@clinique-pasteur.com
Facility Name
Deutsches Herzzentrum Munchen
City
Munich
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Joner, MD
First Name & Middle Initial & Last Name & Degree
Michael Joner, MD
Facility Name
University Hospital Ulm
City
Ulm
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolfgang Rottbauer, MD
First Name & Middle Initial & Last Name & Degree
Wolfgang Rottbauer, MD
Facility Name
Medical University of Silesia
City
Katowice
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wojciech Wojakowski, MD
First Name & Middle Initial & Last Name & Degree
Wojciech Wojakowski, MD
Facility Name
Medical University of Warsaw
City
Warsaw
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zenon Huczek, MD
First Name & Middle Initial & Last Name & Degree
Zenon Huczek, MD
Facility Name
Brighton and Sussex University Hospital
City
Brighton
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Hildick-Smith, MD
First Name & Middle Initial & Last Name & Degree
David Hildick-Smith, MD
12. IPD Sharing Statement
Learn more about this trial
HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve
We'll reach out to this number within 24 hrs