[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"HighLife SAS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":122},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,39,62,81,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100624411","the-embrace-registry-european-post-market-registry-for-catheter-based-mitral-valve-replacement-100624411",false,"NCT07409285","The EMBRACE Registry: European Post-Market Registry for Catheter Based Mitral Valve Replacement","EMBRACE","Inclusion Criteria: Participants must fulfill all following inclusion criteria in order to be included in the post market registry:\n\n1. Participant is indicated for the HighLife TSMVR system per the current approved Instructions For Use (IFU)\n\n   * Participant (≥ 18 years age) with severe or moderately severe mitral valve regurgitation (MR) due to primary (i.e. degenerative) and\u002For secondary (i.e. functional MR.\n   * Left Ventricular Ejection Fraction (LVEF) ≥ 30%\n   * Left ventricular end-diastolic dimension (LVEDD) ≤ 70 mm\n2. Based on the assessment of the local multidisciplinary heart team, the participant is:\n\n   1. unsuitable for heart surgery (mitral valve repair or replacement)\n   2. unsuitable for treatment with transcatheter edge-to-edge repair (complex TEER anatomy)\n   3. eligible to receive the HighLife TSMVR system per the current approved Instructions For Use (IFU) and as assessed by the local heart team\n\nExclusion Criteria: Participants will be excluded from the post market registry as per the current approved Instructions For Use (IFU) if any of the following criteria is met:\n\n1. Significantly calcified mitral valves;\n2. Severe mitral annular calcification\n3. Narrow femoral arteries that don't allow the passage of 18F sheaths;\n4. More than 80 cm between the aortic valve and the femoral access;\n5. Allergies to TSMV or SAI components (bovine tissue, Nitinol, polyester, polyethylene, PTFE);\n6. Intolerance to anticoagulation\u002Fantiplatelet regimens or procedural anticoagulation;\n7. Active bacterial endocarditis or other active infections;\n8. Allergies to contrast media;\n9. Previous implanted aortic valve prosthesis;\n10. Evidence of intracardiac mass, thrombus, or vegetation.\n11. Participant enrolled in another clinical study that may impact the follow-up or results of this study.\n12. Participant has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, may limit the patient's ability to participate in the clinical study or to comply with follow-up requirements.\n13. Tricuspid valve disease requiring intervention","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","3 Years","OBSERVATIONAL","Post-market registry for post-market surveillance, as part of the post-market plan, for the HighLife transcatheter, transseptal, mitral valve replacement system in a real world commercial setting.",[25],"Mitral Regurgitation","NOT_YET_RECRUITING","2026-02-06",{"date":29,"type":30},"2026-02-13","ACTUAL",{"date":32,"type":20},"2026-03-14",{"date":34,"type":20},"2031-04-15",{"name":36,"class":37},"HighLife SAS","INDUSTRY",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":4},"100568630","highlife-clarity-treatment-of-severe-mitral-regurgitation-100568630","NCT06683729","HighLife Clarity Treatment of Severe Mitral Regurgitation","HIGHFIVE","Inclusion Criteria:\n\n* Based on local regulations, the subject meets the legal minimum age to provide informed consent\n* Moderate-to-severe or severe symptomatic MR (≥3+) by transthoracic echocardiography (TTE) which is primarily due to lack of mitral leaflet coaptation, secondary to either a) LV cardiomyopathy with restriction of the mitral leaflet(s), or b) mitral annular dilatation due to chronic atrial fibrillation or other cause, as confirmed by the echocardiographic core laboratory (note: some element of primary (degenerative) MR may be present, but the core lab must agree that the principal etiology is secondary MR)\n* New York Heart Association (NYHA) functional class II, III or ambulatory IV\n* Based on the assessment of the local multidisciplinary heart team, the patient is:\n\n  1. being treated with stable maximally-tolerated doses of guidelines class I indicated GDMT for at least one month, and CRT for at least 3 months (if applicable)\n  2. not indicated for heart surgery (mitral valve repair or replacement) according to guidelines and the local standard of care\n  3. unsuitable for treatment with transcatheter edge-to-edge repair (complex TEER anatomy) as assessed by the site interventional cardiologist(s)\n\nExclusion Criteria:\n\n* Any stroke or TIA within 30 days prior to procedure; any prior intracranial hemorrhage at any time; or any intracerebral mass, arteriovenous fistula or other malformation or defect predisposing to bleeding\n* Known severe carotid stenosis (\\>70% diameter stenosis by non-invasive imaging) or carotid stenting or carotid endarterectomy within 30 days)\n* History of bleeding diathesis, coagulopathy, clotting disorder, or refusal of future blood transfusion or bleeding in the 3 months prior to procedure other than minor cutaneous bleeding\n* Patients in whom transesophageal echo (TEE) is not feasible\n* Chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use.\n* Female subjects of childbearing potential who are not willing or able to comply with the use of contraception, or who are pregnant or lactating, or plan to get pregnant within the next 12 months.\n* Participation in another clinical study of an investigational drug or device at the time of inclusion that has not reached its primary endpoint\n* Patient has known allergies to the device components or contrast medium, which cannot be medically managed\n* Patient cannot tolerate anticoagulation (i.e. warfarin), or not willing to take anticoagulation for at least 6 months, or antiplatelet agents (i.e. aspirin, clopidogrel)\n* Patient with a life expectancy of less than 12 months, or otherwise is unable to comply with the follow-up schedule and assessments",{"count":47,"type":20},240,"INTERVENTIONAL",[50],"NA","The purpose of the study is to evaluate the safety and effectiveness of the HighLife transcatheter trans-septal mitral valve replacement (TSMVR) system in NYHA Class ≥ II-IV patients with moderate-to-severe or severe mitral regurgitation (MR) who, by assessment of the local Heart Team, are unsuitable for treatment with approved transcatheter repair (sub-optimal results to complex or prohibitive edge-to-edge repair) or surgical mitral valve intervention according to guidelines.",[53],"Mitral Valve (MV) Regurgitation","2025-09-09",{"date":56,"type":30},"2025-09-15",{"date":58,"type":20},"2025-12-30",{"date":60,"type":20},"2034-06",{"name":36,"class":37},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":48,"phases":70,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100364755","expanded-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-100364755","NCT04029363","Expanded 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","Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n1. Any stroke\u002FTIA within 30 days\n2. Severe symptomatic carotid stenosis (\\> 70% by non-invasive imaging)\n3. Active infections requiring antibiotic therapy\n4. Active ulcer or gastro-intestinal bleeding in the past 3 months\n5. History of bleeding diathesis, coagulopathy or refusal of future blood transfusion\n6. Patients in whom TEE is not feasible\n7. Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months.\n8. Patient is unable to comply with the follow-up schedule and assessments\n9. Participation in another clinical investigation at the time of inclusion\n10. Patient has known allergies to the device components or contrast medium\n11. Patient cannot tolerate anticoagulation or antiplatelet therapy\n12. Patients with a life expectancy of less than 12 months due to non-cardiac conditions\n13. Patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 3 months\n\n    \\-",{"count":69,"type":20},120,[50],"to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.",[25],"RECRUITING",{"date":56,"type":30},{"date":76,"type":30},"2019-05-28",{"date":78,"type":20},"2031-12-15",{"name":36,"class":37},50,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":48,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100364753","an-early-feasibility-study-of-the-highlife-28mm-trans-septal-transcatheter-mitral-valve-replacement-system-100364753","NCT04029337","An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Severe mitral regurgitation\n* New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.\n* Patient is under maximally tolerated GDMT (incl. CRT) for at least 3 months\n* Multidisciplinary Heart Team consensus that the patient is inoperable or at high-risk for surgical repair\u002Freplacement due to significant co-morbid conditions\n* Multidisciplinary Heart Team consensus that the patient is not a suitable candidate for other approved percutaneous repair therapy due to anatomical or medical conditions\n* Patient meets the anatomical criteria for HighLife valve sizing as determined by CT and TEE\n\nMain Exclusion Criteria:\n\n* Mitral stenosis\n* Rheumatic valve disease\n* Severe calcifications of the mitral annulus and\u002For mitral leaflets\n* Prior surgical or interventional treatment of the mitral valve\n* Unsuitable anatomy for the transapical access\n* Unsuitable anatomy of the aorta and ilio-femoral vessels for the transfemoral access\n* Untreated clinically significant coronary artery disease requiring revascularization\n* LVEF \\\u003C 30%\n* LVEDD \\> 70mm\n* Echocardiographic evidence of intracardiac mass, thrombus or vegetation\n* Hypertrophic Obstructive Cardiomyopathy (HOCM)\n* Any surgical or interventional procedure (including PCI) done in the past 30 days prior to procedure",{"count":88,"type":20},30,[50],"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.",[25],"2025-03-12",{"date":94,"type":30},"2025-03-17",{"date":96,"type":30},"2020-07-14",{"date":98,"type":20},"2030-12",{"name":36,"class":37},10,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":48,"phases":110,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},"100430681","highflo-study---highlife-trans-septal-mitral-valve-replacement-tsmvr-feasibility-study-of-the-open-cell-clarity-valve-100430681","NCT04888247","HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve","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)","HighFLO","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Moderate-severe or severe mitral regurgitation (≥ 3+)\n3. Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV\n4. Patient is under guideline directed medical therapy for at least one month, as reviewed and confirmed by the local multidisciplinary Heart Team\n5. 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\n6. Patient meets the anatomical criteria for HighLife valve\n7. Patient is willing to participate in the study and provides signed informed consent\n8. Patients with a high risk for LVOTO\n\nExclusion Criteria:\n\n1. Any stroke\u002FTIA within 30 days\n2. Severe symptomatic carotid stenosis (\\> 70% by non-invasive imaging)\n3. Active infections requiring antibiotic therapy\n4. Active ulcer or gastro-intestinal bleeding in the past 3 months\n5. History of bleeding diathesis, coagulopathy or refusal of future blood transfusion\n6. Patients in whom TEE is not feasible\n7. Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months.\n8. Patient is unable to comply with the follow-up schedule and assessments\n9. Participation in another clinical investigation at the time of inclusion\n10. Patient has known allergies to the device components or contrast medium\n11. Patient cannot tolerate anticoagulation or antiplatelet therapy\n12. Patients with a life expectancy of less than 12 months due to non-cardiac conditions\n13. Patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 3 months\n\n    \\-",{"count":88,"type":20},[50],"Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system",[25],"2024-10-01",{"date":115,"type":30},"2024-10-03",{"date":117,"type":30},"2021-07-01",{"date":119,"type":20},"2031-02-01",{"name":36,"class":37},14,""]