[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650133":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":40,"locations":46,"responsibleParty":65,"collaborators":67,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":44,"enrollmentInfo":87,"targetDuration":44,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":99,"overallStatus":110,"whyStopped":44,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"University Hospital, Basel, Switzerland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Single-Suture Strategy","ACTIVE_COMPARATOR","Single suture-based vascular closure device (VCD) pre-placed prior to sheath insertion.",[13],"Device: Single Suture-Based Vascular Closure Device",{"label":15,"type":16,"description":17,"interventionNames":18},"Hybrid Strategy (Suture + Plug)","EXPERIMENTAL","Single suture-based VCD combined with an extravascular plug-based VCD (Angio-Seal®)",[19],"Device: Extravascular Collagen Plug-Based Closure Device",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Single Suture-Based Vascular Closure Device","Transfemoral large-bore access site closure using a single pre-placed suture-based vascular closure device (Perclose ProGlide or Perclose ProStyle). The device is deployed at the beginning of the TAVI procedure prior to sheath insertion according to standard manufacturer instructions. Following procedure completion and main sheath removal, the single suture is tied down over a guide wire. Haemostasis is assessed immediately (Grade H0: dry\u002Fno bleeding, or Grade H1: minor oozing\u002Fbleeding controllable with manual compression). Final haemostasis is achieved via manual compression without additional plug adjuncts.",[9],[27,28],"Perclose ProGlide","Perclose ProStyle",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Extravascular Collagen Plug-Based Closure Device","Adjunctive deployment of an extravascular collagen plug-based vascular closure device (Angio-Seal 6F or 8F) following primary single-suture pre-placement. In patients achieving intra-operative Grade H0 (dry) or Grade H1 (minor oozing) haemostasis after primary suture tie-down, the Angio-Seal device is deployed over the retained safety guide wire into the common femoral artery access site to provide secondary extravascular mechanical sealing.",[15],[34],"Angio-Seal",[36],{"name":37,"affiliation":38,"role":39},"Max Wagener, MD, MSc","University Heart Center Basel, University Hospital Basel","PRINCIPAL_INVESTIGATOR",[41],{"name":37,"role":42,"phone":43,"phoneExt":44,"email":45},"CONTACT","+41 61 265 44 44",null,"max.wagener@usb.ch",[47],{"facility":38,"status":44,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Basel","Canton of Basel-City","4031","Switzerland","CH",{"type":54,"coordinates":55},"Point",[56,57],7.57327,47.55839,{"lat":57,"lon":56},[60,61],{"name":37,"role":42,"phone":43,"phoneExt":44,"email":45},{"name":62,"role":42,"phone":63,"phoneExt":44,"email":64},"Felix Mahfound, Prof., MD, MA","+41 61 556 58 10","Felix.Mahfoud@usb.ch",{"type":66,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[68,70,72,74],{"name":69,"class":6},"University Hospital, Zürich",{"name":71,"class":6},"University Heart Center Freiburg - Bad Krozingen",{"name":73,"class":6},"University Hospital Giessen and Marburg",{"name":75,"class":76},"University Hospital Galway","UNKNOWN","100650133","comparing-suture-vs-combined-closure-strategies-for-large-blood-vessel-access-in-patients-undergoing-transcatheter-aortic-valve-implantation-tavi-100650133",false,"NCT07743697","Comparing Suture vs. Combined Closure Strategies for Large Blood Vessel Access in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)","SEAL-TAVI - Suture vs combinEd Closure strAtegies in Large-bore Access After TAVI","SEAL-TAVI","Inclusion Criteria:\n\n* Patient is at least 18 years of age at the time of screening.\n* Patient is scheduled to undergo elective transcatheter aortic valve implantation (TAVI) via transfemoral arterial access.\n* Patient is deemed suitable for transfemoral TAVI and large-bore vascular access closure by the local Heart Team.\n* Patient (or legally authorized representative) provides written informed consent prior to initiating any study-related procedures.\n* Patient is willing and able to comply with all specified study procedures, follow-up visits, and clinical evaluations.\n\nExclusion Criteria:\n\n* Planned TAVI procedure via non-femoral arterial access (e.g., transapical, transaortic, subclavian\u002Faxillary, or carotid access).\n* Emergency or non-elective TAVI procedure.\n* Target main femoral artery vessel diameter, calcification, or tortuosity judged unsuitable for standard percutaneous large-bore vascular closure device deployment.\n* Known active, unresolved local or systemic infection at the planned vascular access site.\n* Known severe allergy or hypersensitivity to bovine tissue, collagen, or any component of the study closure devices (Perclose ProGlide\u002FProStyle or Angio-Seal) that cannot be adequately premedicated.\n* Severe bleeding diathesis, active major bleeding, or absolute contraindication to standard periprocedural anticoagulation or antiplatelet therapy.\n* Concurrent participation in another interventional clinical trial investigating cardiovascular devices or drugs that could confound study endpoints.\n* Patient is pregnant or breastfeeding.\n* Patient belongs to a vulnerable population (e.g., individuals deprived of liberty, under guardianship, or unable to give informed consent).","ALL","18 Years",{"count":88,"type":89},705,"ESTIMATED","INTERVENTIONAL",[92],"NA","The goal of this clinical trial is to compare two strategies for closing the main artery access site in adult patients undergoing transcatheter aortic valve implantation (TAVI) through a blood vessel in the leg (transfemoral access).\n\nThe main questions it aims to answer are:\n\nDoes using a single suture device lower the rate of access-related vascular complications compared to using a hybrid combination of a suture device and a plug-based closure device? How do the two closure strategies compare regarding bleeding complications, procedure time, and time to complete vessel sealing?\n\nResearchers will compare a single-suture closure strategy to a hybrid closure strategy (one suture plus one plug-based device) to see if using a single suture reduces vessel-related complications and improves patient safety after TAVI.\n\nParticipants will:\n\nUndergo standard pre-procedure screening and TAVI via the main artery in the leg as part of routine medical care.\n\nReceive an initial single-suture placement before the large TAVI delivery system is inserted.\n\nBe evaluated after sheath removal for initial bleeding control; qualifying participants will then be randomly assigned (1:1) to either receive no additional device (single suture group) or receive a plug-based closure device (hybrid group).\n\nHave their heart and access site monitored during hospitalization, including laboratory checks and imaging prior to discharge.\n\nComplete a 72-hour safety and complication evaluation.",[95,96,97,98],"Aortic Valve Stenosis","Postoperative Complications","Vascular System Injuries","Hemorrhage",[83,100,101,102,103,34,104,105,106,107,108,109],"Transcatheter Aortic Valve Implantation","TAVI","Vascular Closure Device","Suture-Based Closure","ProGlide","ProStyle","Large-Bore Access","Vascular Complications","TAVR","Transcatheter Aortic Valve Replacement","NOT_YET_RECRUITING","2026-07-29",{"date":113,"type":114},"2026-08-04","ACTUAL",{"date":116,"type":89},"2026-10-01",{"date":118,"type":89},"2028-09",{"name":5,"class":6},1]