[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578837":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":155,"collaborators":20,"id":157,"slug":158,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":20,"eligibilityCriteria":163,"healthyVolunteers":159,"sex":164,"minAge":165,"maxAge":20,"enrollmentInfo":166,"targetDuration":20,"studyType":169,"phases":170,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},{"fullName":5,"class":6},"Biosensors Europe SA","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Biosensors PTV balloon catheter","EXPERIMENTAL","Patients suffering from a severe aortic stenosis and scheduled for a TAVI.",[13],"Device: PTV (Percutaneous Transcatheter Valvuloplasty) Balloon",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","PTV (Percutaneous Transcatheter Valvuloplasty) Balloon","Minimally invasive medical procedure used to replace a diseased aortic valve without the need for open-heart surgery. It is commonly used to treat severe aortic stenosis, a condition in which the aortic valve becomes narrowed and restricts blood flow from the heart to the rest of the body.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Anders Jönsson","CONTACT","0041218048000","a.jonsson@biosensors.com",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Diana Schuette","00447970942022","d.schuette@biosensors.com",[32,50,61,74,88,102,113,127,141],{"facility":33,"status":34,"city":35,"state":20,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Hospital de la Santa Creu i Sant Pau","RECRUITING","Barcelona","08025","Spain","ES",{"type":40,"coordinates":41},"Point",[42,43],2.15899,41.38879,{"lat":43,"lon":42},[46],{"name":47,"role":24,"phone":48,"phoneExt":20,"email":49},"Lluis Asmarats Serra","+34628839525","lasmarats@santpau.cat",{"facility":51,"status":34,"city":35,"state":20,"zip":52,"country":37,"countryCode":38,"cosmosGeoPoint":53,"geoPoint":55,"contacts":56},"Hospital Universitari de Bellvitge","08907",{"type":40,"coordinates":54},[42,43],{"lat":43,"lon":42},[57],{"name":58,"role":24,"phone":59,"phoneExt":20,"email":60},"Rafael Romaguera","+34677592544","rromaguera@bellvitgehospital.cat",{"facility":62,"status":34,"city":63,"state":20,"zip":20,"country":37,"countryCode":38,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Hospital Universitario Reina Sofia","Córdoba",{"type":40,"coordinates":65},[66,67],-4.77275,37.89155,{"lat":67,"lon":66},[70],{"name":71,"role":24,"phone":72,"phoneExt":20,"email":73},"Soledad Ojeda Pineda","+34696662533","soledad.ojeda18@gmail.com",{"facility":75,"status":34,"city":76,"state":20,"zip":77,"country":37,"countryCode":38,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Hospital Universitario Juan Ramon Jimenez","Huelva","21005",{"type":40,"coordinates":79},[80,81],-6.94004,37.26638,{"lat":81,"lon":80},[84],{"name":85,"role":24,"phone":86,"phoneExt":20,"email":87},"Antonio Gomez Menchero","´+34639217965","aegmenchero@gmail.com",{"facility":89,"status":34,"city":90,"state":20,"zip":91,"country":37,"countryCode":38,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Hospital Universitario Ramon y Cajal","Madrid","28034",{"type":40,"coordinates":93},[94,95],-3.70256,40.4165,{"lat":95,"lon":94},[98],{"name":99,"role":24,"phone":100,"phoneExt":20,"email":101},"Luisa Salido Tahoces","+34913368415","luisasalido@gmail.com",{"facility":103,"status":34,"city":90,"state":20,"zip":104,"country":37,"countryCode":38,"cosmosGeoPoint":105,"geoPoint":107,"contacts":108},"Hospital Universitario 12 de Octubre","28041",{"type":40,"coordinates":106},[94,95],{"lat":95,"lon":94},[109],{"name":110,"role":24,"phone":111,"phoneExt":20,"email":112},"Fernando Sarnago, Dr","+34637854412","fernando.sarnago@salud.madrid.org",{"facility":114,"status":34,"city":115,"state":20,"zip":116,"country":37,"countryCode":38,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Hospital Universitario Virgen del Rocio","Seville","41013",{"type":40,"coordinates":118},[119,120],-5.97317,37.38283,{"lat":120,"lon":119},[123],{"name":124,"role":24,"phone":125,"phoneExt":20,"email":126},"José Díaz Francisco Fernández, Dr","+34 616676095","jfdiazf@yahoo.es",{"facility":128,"status":34,"city":129,"state":20,"zip":130,"country":37,"countryCode":38,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Hospital Universitario y Politécnico La Fe","Valencia","46026",{"type":40,"coordinates":132},[133,134],-0.37966,39.47391,{"lat":134,"lon":133},[137],{"name":138,"role":24,"phone":139,"phoneExt":20,"email":140},"Jorge Sanz Sanchez","+34660360598","sjorge4@gmx.com",{"facility":142,"status":34,"city":143,"state":20,"zip":144,"country":37,"countryCode":38,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Hospital Clínico Universitario de Valladolid (HCUV)","Valladolid","47003",{"type":40,"coordinates":146},[147,148],-4.72353,41.65541,{"lat":148,"lon":147},[151],{"name":152,"role":24,"phone":153,"phoneExt":20,"email":154},"Ignacio Amat Santos","+34983420000","ijamat@gmail.com",{"type":156,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100578837","inflate-study-investigation-of-the-safety-and-performance-of-a-novel-ptv-balloon-in-patients-undergoing-tavi-for-severe-aortic-stenosis-100578837",false,"NCT06816485","INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis","Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis","Inclusion Criteria:\n\n1. Symptomatic severe calcific stenosis of a native aortic valve with an AVA ≤1.0 cm2 (or AVA index ≤0.6 cm2\u002Fm2) AND mean aortic pressure gradient ≥ 40mmHg OR maximal transaortic velocity ≥4.0m\u002Fs OR Doppler velocity index ≤0.25 on site-reported echocardiography\n2. Local multi-disciplinary Heart Team agrees on indication and eligibility for TAVI\n3. Age ≥18 years\n4. Patient has signed the Patient Informed Consent Form\n5. Patient is willing and able to comply with requirements of the study\n6. Patients planned for trans-femoral procedure\n\nExclusion Criteria:\n\n1. Mean aortic annulus diameter as measured by pre-procedural CT or internal diameter of the bioprosthesis is \\\u003C16 mm or \\>30 mm\n2. Echocardiographic evidence of intracardiac thrombus, mass or vegetation (site-reported)\n3. Significant disease of the aorta that would preclude safe advancement of the TAVI system\n4. Severe ilio-femoral vessel disease that would preclude safe performance of the TAVI procedure\n5. Severe tricuspid regurgitation and\u002For failing right heart (site-reported)\n6. Severe left ventricular dysfunction with ejection fraction (EF) \\\u003C20% (site-reported)\n7. Evidence of active endocarditis or other acute infections\n8. Renal failure requiring continuous renal replacement therapy\n9. Untreated clinically significant coronary artery disease requiring revascularization\n10. Acute MI ≤30 days prior to the index procedure\n11. Symptomatic carotid or vertebral artery disease requiring intervention or carotid\u002Fvertebral intervention within the preceding 45 days\n12. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) ≤6 months or prior CVA with moderate or severe disability (e.g. modified Rankin scale score \\>2)\n13. History of bleeding diathesis or coagulopathy; acute blood dyscrasias as defined: thrombocytopenia (platelets \\\u003C80,000\u002Fµl), acute anemia (hemoglobin \\\u003C10 g\u002Fdl), leukopenia (WBC \\\u003C3000\u002F µl)\n14. Severe (greater than 3+) mitral insufficiency (site-reported)\n15. Known hypersensitivity to contrast media, which cannot be adequately pre-medicated or contraindication to anticoagulant or anti-platelet medication or to nitinol alloy or to bovine tissue\n16. Currently participating in another investigational drug or device study\n17. Pregnancy or intend to become pregnant during study participation\n18. Unicuspid aortic valve\n19. Non-calcified aortic stenosis\n20. Identified high risk of coronary occlusion due to Sinus of Valsalva anatomy and\u002For bulky calcified aortic valve leaflets in close proximity to coronary ostia\n21. Isolated Aortic Insufficiency\n22. Patients with a permanent pacemaker\n23. Patients with pre-existing LBBB, RBBB and AV block 2 and 3","ALL","18 Years",{"count":167,"type":168},93,"ESTIMATED","INTERVENTIONAL",[171],"NA","This clinical investigation is being done to evaluate the safety and effectiveness of a new device, a PTV Balloon, that will be used to open up an area in the heart (the valve) before and potentially after placing a new valve in patients requiring a new heart valve.\n\nThe main question it aims to answer is:\n\nWhat percentage of patients develop new heart conduction problems after using the investigational PTV Balloon for pre-dilatation?\n\nParticipants will:\n\n1. Undergo a TAVI procedure, where the PTV Balloon will be used for pre-dilatation and may also be used for post-dilatation.\n2. Will be followed up until discharge or up to 7 days, whichever happens first.",[174],"Aortic Diseases",[176,177,178,179],"PTV Balloon","TAVI","Aortic Valve Stenosis","Balloon Aortic Valvuloplasty","2026-04-15",{"date":182,"type":183},"2026-04-16","ACTUAL",{"date":185,"type":183},"2025-12-15",{"date":187,"type":168},"2026-08",{"name":5,"class":6},9]