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Feasibility Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk

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ClinicalTrials.gov Identifier: NCT04029363
Recruitment Status : Recruiting
First Posted : July 23, 2019
Last Update Posted : June 22, 2022
Sponsor:
Collaborator:
MedPass International
Information provided by (Responsible Party):
HighLife SAS

Study Description
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Brief Summary:
to evaluate the feasibility, safety and performance of the HighLife 28mm Transcatheter Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Device: HighLife Transcatheter Mitral Valve Replacement Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : October 2027
Arms and Interventions
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Arm Intervention/treatment
Single arm
Single arm, non-randomized
 Device: HighLife Transcatheter Mitral Valve Replacement
Transcatheter Mitral Valve Replacement


Outcome Measures
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Primary Outcome Measures :
  1. Device Safety [ Time Frame: 30 days ]
    Freedom from major adverse events


Eligibility Criteria
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Information from the National Library of Medicine

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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, as reviewed and confirmed by the local multidisciplinary Heart Team, for at least one month 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

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

    -

Contacts and Locations
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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): NCT04029363


Contacts
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Contact: Martin Rothman, MD +1 707 2177167 MRothman@highlifemed.com

Locations
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Sponsors and Collaborators
HighLife SAS
MedPass International
More Information
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Responsible Party: HighLife SAS
ClinicalTrials.gov Identifier: NCT04029363    
Other Study ID Numbers: HL-2018-01-TS Feasibility
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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