[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569099":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":31,"locations":37,"responsibleParty":219,"collaborators":221,"id":227,"slug":228,"hasResults":229,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":229,"sex":235,"minAge":236,"maxAge":25,"enrollmentInfo":237,"targetDuration":25,"studyType":240,"phases":241,"briefSummary":243,"conditions":244,"keywords":247,"overallStatus":61,"whyStopped":25,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":262},{"fullName":5,"class":6},"EnCompass Technologies, Inc.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"F2 Filter and Delivery System","EXPERIMENTAL","The F2 Cerebral Embolic Protection System will be used during your Transcatheter Aortic Valve Replacement procedure",[13,14],"Device: F2 Filter and Delivery System","Procedure: Transcatheter Aortic Valve Replacement (TAVR)",{"label":16,"type":17,"description":18,"interventionNames":19},"Either the Sentinel Cerebral Protection System or no embolic protection device","ACTIVE_COMPARATOR","Either the Sentinel Cerebral Protection System or no embolic protection device will be used during your Transcatheter Aortic Valve Replacement procedure depending on the Standard of Care at the treating institution",[14],[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Use of the F2 Filter and Delivery System in conjunction with a Transcatheter Aortic Valve Replacement (TAVR) procedure",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"PROCEDURE","Transcatheter Aortic Valve Replacement (TAVR)","Transcatheter Aortic Valve Replacement (TAVR) with commercially available Transcatheter Aortic Valve Replacement (TAVR) device",[16,9],[32],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Kathleen S Calderon","CONTACT","3072502726","kcalderon@encompassf2.com",[38,59,72,93,111,131,148,168,185,203],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"NCH Baker Hospital-Naples Heart Institute","NOT_YET_RECRUITING","Naples","Florida","34102","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-81.79596,26.14234,{"lat":50,"lon":49},[53,56],{"name":54,"role":34,"phone":55,"phoneExt":25,"email":25},"Kathy Byrd","(239)624-8113",{"name":57,"role":58,"phone":25,"phoneExt":25,"email":25},"Robert Cubeddu","PRINCIPAL_INVESTIGATOR",{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":44,"countryCode":45,"cosmosGeoPoint":25,"geoPoint":25,"contacts":65},"St. Vincent Hospital","RECRUITING","Indianappolis","Indiana","46260",[66,70],{"name":67,"role":34,"phone":68,"phoneExt":25,"email":69},"Kelly 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City","Missouri","64111",{"type":47,"coordinates":99},[100,101],-94.57857,39.09973,{"lat":101,"lon":100},[104,107],{"name":105,"role":34,"phone":25,"phoneExt":25,"email":106},"Caroline Kempter","ckempter@saint-lukes.org",{"name":108,"role":34,"phone":109,"phoneExt":25,"email":110},"Anne Hoffman","816-932-5707","ahoffman@saint-lukes.org",{"facility":112,"status":61,"city":113,"state":113,"zip":114,"country":44,"countryCode":45,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Cumc\u002FNyph","New York","10032",{"type":47,"coordinates":116},[117,118],-74.00597,40.71427,{"lat":118,"lon":117},[121,125,129],{"name":122,"role":34,"phone":123,"phoneExt":25,"email":124},"Kate Dalton","212-342-1820","keb2114@columbia.edu",{"name":126,"role":34,"phone":25,"phoneExt":127,"email":128},"Treena Williams","212-342-3485","taw2112@columbia.edu",{"name":130,"role":58,"phone":25,"phoneExt":25,"email":25},"Torsten Vahl, MD",{"facility":132,"status":61,"city":133,"state":134,"zip":135,"country":44,"countryCode":45,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Cleveland Clinic Foundation","Cleveland","Ohio","44195",{"type":47,"coordinates":137},[138,139],-81.69541,41.4995,{"lat":139,"lon":138},[142,146],{"name":143,"role":34,"phone":144,"phoneExt":25,"email":145},"Emily Tylicki","216-287-8237","TYLICKE@ccf.org",{"name":147,"role":58,"phone":25,"phoneExt":25,"email":25},"Amar Krishnaswamy, MD",{"facility":149,"status":40,"city":150,"state":134,"zip":151,"country":44,"countryCode":45,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Ohio Health Research Institute (aka Riverside Methodist Hospital)","Columbus","43214",{"type":47,"coordinates":153},[154,155],-82.99879,39.96118,{"lat":155,"lon":154},[158,162,166],{"name":159,"role":34,"phone":160,"phoneExt":25,"email":161},"Maureen McCormack","(614) 788-3885","Maureen.McCormack@ohiohealth.com",{"name":163,"role":34,"phone":164,"phoneExt":25,"email":165},"Christina Belcher","614-813-4555","christina.belcher@ohiohealth.com",{"name":167,"role":58,"phone":25,"phoneExt":25,"email":25},"Steven Yakubov, MD",{"facility":169,"status":40,"city":170,"state":171,"zip":172,"country":44,"countryCode":45,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"University of Virginia Medical Center","Charlottesville","Virginia","22903",{"type":47,"coordinates":174},[175,176],-78.47668,38.02931,{"lat":176,"lon":175},[179,183],{"name":180,"role":34,"phone":181,"phoneExt":25,"email":182},"Linda Bailes Bryceland","434-982-1058","LGS2M@uvahealth.org",{"name":184,"role":58,"phone":25,"phoneExt":25,"email":25},"John Saxon",{"facility":186,"status":40,"city":187,"state":188,"zip":189,"country":190,"countryCode":191,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"St Andrews War Memorial Hospital","Spring Hill","Queensland","4000","Australia","AU",{"type":47,"coordinates":193},[194,195],153.02311,-27.46141,{"lat":195,"lon":194},[198,201],{"name":199,"role":34,"phone":25,"phoneExt":25,"email":200},"Linda Pearce","linda.pearce@wesleyresearch.org.au",{"name":202,"role":58,"phone":25,"phoneExt":25,"email":25},"Karl Poon, MD",{"facility":204,"status":61,"city":205,"state":206,"zip":207,"country":190,"countryCode":191,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Monash Health Public","Clayton","Victoria","3168",{"type":47,"coordinates":209},[210,211],145.11667,-37.91667,{"lat":211,"lon":210},[214,217],{"name":215,"role":34,"phone":25,"phoneExt":25,"email":216},"Trazzie Luk","TszTing.Luk@monashhealth.org",{"name":218,"role":58,"phone":25,"phoneExt":25,"email":25},"Robert Gooley, MD",{"type":220,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[222,224],{"name":223,"class":6},"Avania",{"name":225,"class":226},"Insight Medical Consulting","UNKNOWN","100569099","trial-of-the-f2-filter-and-delivery-system-for-embolic-protection-during-tavr-100569099",false,"NCT06689839","Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR","A Prospective, Randomized, Multicenter, Single-blind Trial to Assess the Safety and Effectiveness of the Encompass F2 Cerebral Protection System Vs. Standard of Care (Unprotected or Sentinel® Cerebral Protection System) During Transfemoral Transcatheter Aortic Valve Replacement","SHIELD","Key Inclusion Criteria:\n\n* Age ≥ 50 years.\n* Patient meets the established criteria and indications for commercially available TAVR via transfemoral access and is scheduled to undergo TAVR per their treating physician.\n* Patient is willing and able to comply with protocol-specified follow-up evaluations.\n* Patient is able and willing to provide written informed consent.\n* Patient meets all criteria for use of control device (Sentinel device, per IFU).\n\nKey Exclusion Criteria:\n\nGeneral Exclusion Criteria:\n\n* Patient requires an urgent or emergent TAVR procedure.\n* Any interventional cardiovascular procedure performed within 30 days prior to TAVR procedure or planned within 30 days post-TAVR procedure.\n* Diagnostic cardiac catheterization within 10 days prior to TAVR procedure.\n* Evidence of an acute myocardial infarction within 3 months prior to TAVR procedure.\n* Prior prosthetic heart valve in any position.\n* Known intracardiac thrombus.\n* Active infection or endocarditis.\n* Patient is contraindicated for anti-platelet and\u002For anticoagulant therapy.\n* Patient refuses blood transfusion.\n* Renal insufficiency (creatinine \\> 2.5 mg\u002FdL or GFR \\\u003C 30) and\u002For renal replacement therapy at the time of screening.\n* Patients with hepatic failure (Child-Pugh class C).\n* Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \\\u003C 30%.\n* Females who are pregnant or nursing or plan to become pregnant during their participation in the study.\n\nNeurological Exclusion Criteria:\n\n* Modified Rankin Scale (mRS) ≥ 2 at screening.\n* Cerebrovascular event including TIA within 6 months of the procedure.\n* Patient has active major psychiatric disease, known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol or confound the data interpretation.\n* Patient has severe visual, auditory, or learning impairment.\n* Patient has neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.\n\nMagnetic Resonance Imaging Exclusion Criteria:\n\n* Contraindications to MRI (participants with MR unsafe implants including implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure).\n* High risk of complete AV block after TAVR, with the need of permanent pacemaker.\n* Claustrophobia precluding MRI scanning.\n\nAnatomical and CT Exclusion Criteria:\n\n* Severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery sheath, vascular access or filter deployment.\n* Presence of cardiovascular implant in aorta and\u002For peripheral access vessels.\n* Access vessels with excessive tortuosity.\n* Aortic arch, which is heavily calcified, severely atheromatous, or severely tortuous.","ALL","50 Years",{"count":238,"type":239},500,"ESTIMATED","INTERVENTIONAL",[242],"NA","The objective of this study is to compare the safety and effectiveness of the F2 Cerebral Protection System (CPS) to a standard of care control group in patients undergoing Transcatheter Aortic Valve Replacement (TF TAVR)",[245,246],"Aortic Stenosis Treated With TAVI","Aortic Diseases",[248,249,250,251,252],"Embolic Protection","Transcatheter Aortic Valve Replacement","TAVR","Aortic Valve Stenosis","Aortic Valve Diseases","2025-11-19",{"date":255,"type":256},"2025-11-20","ACTUAL",{"date":258,"type":256},"2025-09-09",{"date":260,"type":239},"2027-01",{"name":5,"class":6},10]