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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04888247
Recruitment Status : Recruiting
First Posted : May 17, 2021
Last Update Posted : June 21, 2022
Sponsor:
Information provided by (Responsible Party):
HighLife SAS

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

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Device: CLARITY Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : January 1, 2028

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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04888247


Contacts
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Contact: Luc Verhees +31 6 4270 2457 lverhees@highlifemed.com

Locations
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Australia
Wesley Hospital Recruiting
Auchenflower, Australia
Contact: Anthony Camuglia, MD         
Principal Investigator: Anthony Camuglia, MD         
Mount Hospital Recruiting
Perth, Australia
Contact: Wen Yeow, MD    +61 8 9400 6217    wyeow@heartwest.com.au   
Principal Investigator: Wen Yeow, MD         
Macquarie University Hospital Recruiting
Sydney, Australia
Contact: Stephen Worthley, MD         
Principal Investigator: Stephen Worthley, MD         
Belgium
AZ St. Jan - Brugge Recruiting
Brugge, Belgium
Contact: Jan van der Heyden, MD         
Principal Investigator: Jan van der Heyden, MD         
UZ Leuven Recruiting
Leuven, Belgium
Contact: Christophe Dubois, MD         
Principal Investigator: Christophe Dubois, MD         
France
CHU de Rennes Recruiting
Rennes, France
Contact: Guillaume Leurent, MD         
Principal Investigator: Guillaume Leurent, MD         
Cliniue Pasteur Recruiting
Toulouse, France, 31076
Contact: Didier Tchetche    +33562211699    dtchetche@clinique-pasteur.com   
Germany
Deutsches Herzzentrum Munchen Recruiting
Munich, Germany
Contact: Michael Joner, MD         
Principal Investigator: Michael Joner, MD         
University Hospital Ulm Recruiting
Ulm, Germany
Contact: Wolfgang Rottbauer, MD         
Principal Investigator: Wolfgang Rottbauer, MD         
Poland
Medical University of Silesia Not yet recruiting
Katowice, Poland
Contact: Wojciech Wojakowski, MD         
Principal Investigator: Wojciech Wojakowski, MD         
Medical University of Warsaw Recruiting
Warsaw, Poland
Contact: Zenon Huczek, MD         
Principal Investigator: Zenon Huczek, MD         
United Kingdom
Brighton and Sussex University Hospital Recruiting
Brighton, United Kingdom
Contact: David Hildick-Smith, MD         
Principal Investigator: David Hildick-Smith, MD         
Sponsors and Collaborators
HighLife SAS
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Responsible Party: HighLife SAS
ClinicalTrials.gov Identifier: NCT04888247    
Other Study ID Numbers: HL-2021-01
First Posted: May 17, 2021    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases