[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04029337":3,"trial-entities:NCT04029337":211,"trial-summary:NCT04029337":215},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":33,"secondary_outcomes":41,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":73,"locations":76,"central_contacts":207,"overall_officials":208,"references":209,"see_also_links":210},"NCT04029337","HL-2019-01","An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System","RECRUITING","2030-12","2025-03","2025-03-17","2020-07-14","HighLife SAS","INDUSTRY",true,"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.","Protocol Title:\n\nAn Early Feasibility Study of the HighLife 28mm Transcatheter Trans-Septal Mitral Valve Replacement System\n\nProtocol # HL-2019-01, ver. 5.0\n\nPhase: United States Early Feasibility Study\n\nInvestigational Devices:\n\nThe HighLife 28mm Trans-Septal Mitral Valve and its delivery systems. These devices compose the HighLife Trans-septal Mitral Valve Replacement (TSMVR) System.\n\n* Size 28 mm TMV (CLARITY valve)\n* Size 28 mm TMV-L (CLARITY large annulus valve\u002F LAV)\n\nIntended Use: The HighLife TSMVR system is intended for the trans-septal access percutaneous mitral valve replacement in patients suffering from symptomatic moderate-severe or severe mitral regurgitation (MR) due to primary (degenerative) or secondary (functional) abnormality of the mitral valve.\n\nDevice Description:\n\nThe HighLife TSMVR system is composed of a Trans-Septal (Mitral Valve (TSMV), a sub-annular implant (SAI), and their delivery systems and accessories. The TMV is a 28 mm mitral bioprosthesis made of a self-expanding Nitinol frame covered with polyester graft and supporting bovine pericardium leaflets. The bioprosthesis is used in conjunction with the Sub-Annular Implant (SAI), comprising a ring (made of polycarbonate urethane (PCU), nitinol, gold markers and polyester (Dacron) to be placed around the mitral valve apparatus to stabilize the position of the mitral valve implant.\n\nDesign: A single arm, prospective, multicenter, non-randomized and open-labelled study.\n\nPurpose: The purpose of the study is to evaluate the feasibility, safety and performance of the HighLife 28mm Trans-septal Mitral Valve Replacement (TSMVR) system in NYHA Class ≥ II-IV patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment or deemed more appropriate to receive transcatheter mitral valve replacement than to receive conventional mitral valve surgery according to the local multidisciplinary Heart Team.\n\nObjectives: Primary objectives are to evaluate the feasibility, safety and performance of the HighLife 28mm TSMVR system at 30 days. Secondary objectives are to evaluate long term safety and performance of the HighLife TSMVR system.",[18],"Mitral Regurgitation",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},30,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","Transcatheter Mitral Valve Replacement","Minimally invasive transcatheter mitral valve implantation using the HighLife™ TMVR system",[30],[34,38],{"measure":35,"description":36,"timeFrame":37},"Freedom of major adverse events","including:\n\n* All-cause mortality\n* Myocardial infarction or coronary ischemia requiring PCI or CABG\n* Major stroke\n* Life-threatening bleeding (MVARC scale)\n* Major access and vascular complications\n* Stage 2 or 3 acute kidney injury (includes dialysis)\n* Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention\n* Severe hypotension, heart failure or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for ≥ 48H","at 30 days post procedure",{"measure":39,"description":40,"timeFrame":37},"Continued intended performance of the HighLife™ bioprosthesis","defined as the reduction of mitral regurgitation (MR) to either optimal (0+ to trace) or acceptable (reduced by at least 1 grade from baseline with no more than 2+ MR) without significant mitral stenosis (post-procedure EOA ≥ 1.5 cm2 with a transmitral gradient \\\u003C 5mmHg) and with no greater than mild (1+) paravalvular MR (and without associated hemolysis)",[42],{"measure":43,"description":44,"timeFrame":45},"Technical success","defined as alive patient at exit from procedure room, with all of the following:\n\n* Successful access, delivery and retrieval of the HighLife delivery systems\n* Deployment and correct positioning of the HighLife bioprosthesis\n* Freedom of additional emergency surgery or re-intervention related to the device or access procedure","immediately after procedure","ALL","18 Years",null,false,{"inclusion":51,"exclusion":59,"raw_text":72},[52,53,54,55,56,57,58],"Age ≥ 18 years","Severe mitral regurgitation","New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.","Patient is under maximally tolerated GDMT (incl. CRT) for at least 3 months","Multidisciplinary Heart Team consensus that the patient is inoperable or at high-risk for surgical repair\u002Freplacement due to significant co-morbid conditions","Multidisciplinary Heart Team consensus that the patient is not a suitable candidate for other approved percutaneous repair therapy due to anatomical or medical conditions","Patient meets the anatomical criteria for HighLife valve sizing as determined by CT and TEE",[60,61,62,63,64,65,66,67,68,69,70,71],"Mitral stenosis","Rheumatic valve disease","Severe calcifications of the mitral annulus and\u002For mitral leaflets","Prior surgical or interventional treatment of the mitral valve","Unsuitable anatomy for the transapical access","Unsuitable anatomy of the aorta and ilio-femoral vessels for the transfemoral access","Untreated clinically significant coronary artery disease requiring revascularization","LVEF \\\u003C 30%","LVEDD \\> 70mm","Echocardiographic evidence of intracardiac mass, thrombus or vegetation","Hypertrophic Obstructive Cardiomyopathy (HOCM)","Any surgical or interventional procedure (including PCI) done in the past 30 days prior to procedure","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",[74,75],"ADULT","OLDER_ADULT",[77,92,107,121,134,148,162,171,185,199],{"facility":78,"status":7,"city":79,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":89},"Tucson Medical Center","Tucson","Arizona","85712","United States",[84],{"name":85,"role":86,"phone":87,"email":88},"Thomas Waggoner, MD","CONTACT","+1 520-838-3540","Thomas Waggoner \u003Ctwaggoner.med@gmail.com>",{"lat":90,"lon":91},32.22174,-110.92648,{"facility":93,"status":7,"city":94,"state":95,"zip":96,"country":82,"contacts":97,"geoPoint":104},"Los Robles Regional Medical Center","Los Angeles","California","91360",[98,102],{"name":99,"role":86,"phone":100,"email":101},"Saibal Kar, MD","(805) 497-2727","saibalkar60@gmail.com",{"name":99,"role":103},"PRINCIPAL_INVESTIGATOR",{"lat":105,"lon":106},34.05223,-118.24368,{"facility":108,"status":7,"city":109,"state":110,"zip":111,"country":82,"contacts":112,"geoPoint":118},"Piedmont Heart","Atlanta","Georgia","30309",[113,117],{"name":114,"role":86,"phone":115,"email":116},"Pradeep Yadav, MD","(404) 605-5000","pradeep.yadav@piedmont.org",{"name":114,"role":103},{"lat":119,"lon":120},33.749,-84.38798,{"facility":122,"status":7,"city":123,"state":124,"zip":125,"country":82,"contacts":126,"geoPoint":131},"Brigham and Women's Hospital","Boston","Massachusetts","02115",[127],{"name":128,"role":86,"phone":129,"email":130},"Pinank Shah, MD","+1 857-307-4000","pbshah@bwh.harvard.edu",{"lat":132,"lon":133},42.35843,-71.05977,{"facility":135,"status":7,"city":136,"state":137,"zip":138,"country":82,"contacts":139,"geoPoint":145},"Minneapolis Heart","Minneapolis","Minnesota","55407",[140,144],{"name":141,"role":86,"phone":142,"email":143},"Paul Sorajja, MD","(612) 863-3900","paul.sorajja@allina.com",{"name":141,"role":103},{"lat":146,"lon":147},44.97997,-93.26384,{"facility":149,"status":7,"city":150,"state":150,"zip":151,"country":82,"contacts":152,"geoPoint":159},"Montefiore Medical Center","New York","10467",[153,157],{"name":154,"role":86,"phone":155,"email":156},"Azeem Latib, MD","(718) 920-4321","mlatib@montefiore.org",{"name":158,"role":103},"Azim Latib, MD",{"lat":160,"lon":161},40.71427,-74.00597,{"facility":163,"status":164,"city":165,"state":166,"zip":167,"country":82,"geoPoint":168},"University of Pennsylvania","TERMINATED","Philadelphia","Pennsylvania","19104",{"lat":169,"lon":170},39.95238,-75.16362,{"facility":172,"status":7,"city":173,"state":174,"zip":175,"country":82,"contacts":176,"geoPoint":182},"Medical University of South Carolina","Charleston","South Carolina","29425",[177,181],{"name":178,"role":86,"phone":179,"email":180},"Daniel Steinberg, MD","(843) 792-1414","steinbe@musc.edu",{"name":178,"role":103},{"lat":183,"lon":184},32.77632,-79.93275,{"facility":186,"status":7,"city":187,"state":188,"zip":189,"country":82,"contacts":190,"geoPoint":196},"Houston Methodist Hospital","Houston","Texas","77030",[191,195],{"name":192,"role":86,"phone":193,"email":194},"Sachin Goel, MD","(713) 790-3311","ssgoel@houstonmethodist.org",{"name":192,"role":103},{"lat":197,"lon":198},29.76328,-95.36327,{"facility":200,"status":164,"city":201,"state":202,"zip":203,"country":82,"geoPoint":204},"Chippenham Hospital Richmond","Richmond","Virginia","23225",{"lat":205,"lon":206},37.55376,-77.46026,[],[],[],[],{"nct_id":4,"conditions":212,"biomarkers":214},[213],"Mitral Valve Insufficiency",[],{"nct_id":4,"found":14,"summary":216,"prompt_version":226},{"design":217,"status":218,"heading":219,"summary":220,"follow_up":221,"word_count":222,"commitments":223,"compensation":224,"drugs_mentioned":225},"This is an early feasibility study, meaning it's one of the first times this device is being tested in people. It is an interventional study, and 30 participants are planned.","completed","HighLife Transcatheter Mitral Valve Replacement for Mitral Regurgitation","This study is testing a new device called the HighLife Transcatheter Mitral Valve Replacement (TMVR) System. This system is designed to replace a leaky mitral valve without open-heart surgery. It's for people with severe mitral regurgitation (a condition where the heart's mitral valve doesn't close properly, causing blood to flow backward) who are too sick for traditional surgery. The study will look at the safety of the device and how well it works after 30 days. You might be able to join if you are at least 18 years old, have severe mitral regurgitation, and your doctors believe surgery is too risky for you. The study aims to enroll 30 participants.","Participants will be followed for at least 30 days after the procedure to check for major adverse events and how well the device is working.",111,"Not specified in the trial record.","Not stated in the trial record.",[30],"v2"]