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An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

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: NCT04029337
Recruitment Status : Recruiting
First Posted : July 23, 2019
Last Update Posted : October 24, 2022
Sponsor:
Information provided by (Responsible Party):
HighLife SAS

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

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

Study Design
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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: An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
Actual Study Start Date : July 14, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2027
Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Device: HighLife Transcatheter Mitral Valve Replacment
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+)

    • For Degenerative MR: EROA ≥ 40 mm2 or regurgitant volume ≥ 60ml
    • For Secondary MR: EROA > 30 mm2 or regurgitant volume > 45ml (i.e., MR ≥ moderate-severe or severe by ASE criteria) 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): NCT04029337


Locations
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United States, California
Los Robles Regional Medical Center Recruiting
Los Angeles, California, United States, 91360
Contact: Saibal Kar, MD    805-497-2727    saibalkar60@gmail.com   
Principal Investigator: Saibal Kar, MD         
United States, Georgia
Piedmont Heart Recruiting
Atlanta, Georgia, United States, 30309
Contact: Pradeep Yadav, MD    404-605-5000    pradeep.yadav@piedmont.org   
Principal Investigator: Pradeep Yadav, MD         
United States, Minnesota
Minneapolis Heart Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Paul Sorajja, MD    612-863-3900    paul.sorajja@allina.com   
Principal Investigator: Paul Sorajja, MD         
United States, New York
Montefiore Medical Center Recruiting
New York, New York, United States, 10467
Contact: Azeem Latib, MD    718-920-4321    mlatib@montefiore.org   
Principal Investigator: Azim Latib, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Howard Herrmann, MD    215-898-5000    howard.herrmann@pennmedicine.upenn.edu   
Principal Investigator: Howard Herrmann, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Daniel Steinberg, MD    843-792-1414    steinbe@musc.edu   
Principal Investigator: Daniel Steinberg, MD         
United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Sachin Goel, MD    713-790-3311    ssgoel@houstonmethodist.org   
Principal Investigator: Sachin Goel, MD         
United States, Virginia
Chippenham Hospital Richmond Recruiting
Richmond, Virginia, United States, 23225
Contact: Scott Lim, MD    804-483-0000    SL9PC@virginia.edu   
Principal Investigator: Scott Lim, MD         
Sponsors and Collaborators
HighLife SAS
More Information
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Responsible Party: HighLife SAS
ClinicalTrials.gov Identifier: NCT04029337    
Other Study ID Numbers: HL-2019-01
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: October 24, 2022
Last Verified: October 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: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases