An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mitral Regurgitation | Device: HighLife Transcatheter Mitral Valve Replacment | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: Single |
Device: HighLife Transcatheter Mitral Valve Replacment
Transcatheter mitral valve replacement |
- Device Safety [ Time Frame: 30 days ]Freedom from major adverse events

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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:
- 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
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Patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 3 months
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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
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 |
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 |
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 |
Mitral Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases |