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

November 28, 2023 updated by: HighLife SAS

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Auchenflower, Australia
        • Recruiting
        • Wesley Hospital
        • Principal Investigator:
          • Anthony Camuglia, MD
        • Contact:
          • Anthony Camuglia, MD
      • Perth, Australia
        • Recruiting
        • Mount Hospital
        • Principal Investigator:
          • Wen Yeow, MD
        • Contact:
      • Sydney, Australia
        • Terminated
        • Macquarie University Hospital
  • Belgium
      • Brugge, Belgium
        • Recruiting
        • AZ St. Jan - Brugge
        • Contact:
          • Jan van der Heyden, MD
        • Principal Investigator:
          • Jan van der Heyden, MD
      • Leuven, Belgium
        • Recruiting
        • UZ Leuven
        • Principal Investigator:
          • Christophe Dubois, MD
        • Contact:
          • Christophe Dubois, MD
  • France
      • Lille, France, 59000
      • Nantes, France, 44000
      • Rennes, France
        • Recruiting
        • CHU de Rennes
        • Contact:
          • Guillaume Leurent, MD
        • Principal Investigator:
          • Guillaume Leurent, MD
      • Toulouse, France, 31076
  • Germany
      • Munich, Germany
        • Recruiting
        • Deutsches Herzzentrum München
        • Contact:
          • Michael Joner, MD
        • Principal Investigator:
          • Michael Joner, MD
      • Ulm, Germany
        • Recruiting
        • University Hospital Ulm
        • Contact:
          • Wolfgang Rottbauer, MD
        • Principal Investigator:
          • Wolfgang Rottbauer, MD
  • Poland
      • Katowice, Poland
        • Recruiting
        • Medical University of Silesia
        • Principal Investigator:
          • Wojciech Wojakowski, MD
        • Contact:
          • Wojciech Wojakowski, MD
      • Warsaw, Poland
        • Recruiting
        • Medical University of Warsaw
        • Contact:
          • Zenon Huczek, MD
        • Principal Investigator:
          • Zenon Huczek, MD
  • United Kingdom
      • Brighton, United Kingdom
        • Recruiting
        • Brighton and Sussex University Hospital
        • Contact:
          • David Hildick-Smith, MD
        • Principal Investigator:
          • David Hildick-Smith, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Trans-septal mitral valve replacement
Device: CLARITY
Trans-septal mitral valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of subjects meeting Technical Success
Time Frame: 24 hours
  • 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HighLife SAS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

February 1, 2030

Study Registration Dates

First Submitted

May 4, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (Actual)

May 17, 2021

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL-2021-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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