Trial record 3 of 3 for:
highlife
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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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: NCT04029363 |
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Recruitment Status :
Recruiting
First Posted : July 23, 2019
Last Update Posted : December 1, 2020
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Sponsor:
HighLife SAS
Collaborator:
MedPass International
Information provided by (Responsible Party):
HighLife SAS
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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 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 : | July 2021 |
| Estimated Study Completion Date : | July 2025 |
Intervention Details:
- Device: HighLife Transcatheter Mitral Valve Replacement
Transcatheter Mitral Valve Replacement
Primary Outcome Measures :
- 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 |
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:
- 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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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
| Contact: Martin Rothman, MD | +1 707 2177167 | MRothman@highlifemed.com |
Locations
Show 23 study locations
Sponsors and Collaborators
HighLife SAS
MedPass International
| 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: | December 1, 2020 |
| Last Verified: | November 2020 |
| 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: | No |
Additional relevant MeSH terms:
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Mitral Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases |