[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"EnCompass Technologies, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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":20,"type":21},500,"ESTIMATED","INTERVENTIONAL",[24],"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)",[27,28],"Aortic Stenosis Treated With TAVI","Aortic Diseases",[30,31,32,33,34],"Embolic Protection","Transcatheter Aortic Valve Replacement","TAVR","Aortic Valve Stenosis","Aortic Valve Diseases","RECRUITING","2025-11-19",{"date":38,"type":39},"2025-11-20","ACTUAL",{"date":41,"type":39},"2025-09-09",{"date":43,"type":21},"2027-01",{"name":45,"class":46},"EnCompass Technologies, Inc.","INDUSTRY",10,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100505842","early-phase-1-feasibility-trial-of-the-f2-filter-and-delivery-system-for-embolic-protection-during-tavr-100505842","NCT05866640","Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR","A Prospective, Single-Arm, Single Center Feasibility Trial to Evaluate the Safety and Performance of the F2 Filter and Delivery System Used for Embolic Protection During Transcatheter Aortic Valve Replacement","Inclusion Criteria:\n\ncriteria:\n\n1. Age ≥ 22 years.\n2. The patient meets the established criteria and indications for commercially available TAVR (Edwards\u002FMedtronic) for transfemoral access.\n3. Montreal Cognitive Assessment (MoCA) score ≥ 26 at screening.\n4. The patient is willing and able to comply with protocol-specified follow-up evaluations.\n5. The patient or legally authorized representative is able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. Contraindications to MRI (e.g., subjects 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, or claustrophobia).\n2. Severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery sheath vascular access or filter deployment.\n3. Patients in whom the aortic arch is heavily calcified, severely atheromatous, or severely tortuous.\n4. Ascending aortic diameter \\> 38 mm or transverse aortic diameter \\> 27 mm.\n5. Evidence of an acute myocardial infarction within 1 month before TAVR.\n6. Pre-existing prosthetic heart valve or prosthetic ring in any position.\n7. Known intracardiac thrombus.\n8. Severe allergy or known hypersensitivity or contraindication to aspirin, heparin\u002Fbivalirudin, clopidogrel, nitinol, stainless steel alloy, and\u002For contrast sensitivity that cannot be adequately pre-medicated.\n9. History of bleeding diathesis or coagulopathy or patients in whom anti-platelet and\u002For anticoagulant therapy is contraindicated.\n10. Patients who refuse blood transfusion.\n11. Active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 3 months.\n12. Recent (within 6 months) CVA or a TIA.\n13. Renal insufficiency (creatinine \\> 2.5 mg\u002FdL or GFR \\\u003C 30) and\u002For renal replacement therapy at the time of screening.\n14. Patients with hepatic failure (Child-Pugh class C).\n15. Patients with hypercoagulable states that cannot be corrected by additional periprocedural heparin.\n16. Patients presenting with cardiogenic shock or requiring vasopressor or inotropic support at the time of the index procedure.\n17. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \\\u003C 20%.\n18. Life expectancy \\\u003C 12 months.\n19. Currently participating in an investigational drug or another device study that has not completed the initial primary endpoint evaluation (e.g., long term follow-up study\u002Fcontinued access study subjects are able to be included).\n20. Subjects who have had treatment with any other investigational device within 30 days prior to study enrollment.\n21. Planned surgery or invasive procedure within 30 days following the index procedure (TAVR with F2 Filter).\n22. Patients planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 10 days prior to the TAVR procedure. NOTE: Balloon valvuloplasty during TAVR is permitted. Diagnostic cardiac catheterization is permitted within 10 days prior to the TAVR procedure.\n23. Patients with known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol or confound the data interpretation.\n24. Females who are pregnant or nursing or plan to become pregnant during their participation in the study. Female subjects of child-bearing potential must have a negative pregnancy test at screening.\n25. Any other condition that in the opinion of the investigator, precludes study participation or poses a significant hazard to the patient.\n\n    \\-","22 Years",{"count":47,"type":21},[58],"EARLY_PHASE1","The goal of this clinical trial is to learn about the safety and performance of the F2 device for cerebral embolic protection in participants with symptomatic aortic stenosis underdoing a Transcatheter Aortic Valve replacement procedure.\n\nParticipants will complete several neurocognitive assessments and an MRI procedure.",[61],"Aortic Stenosis",[32],"2025-02-24",{"date":65,"type":39},"2025-02-25",{"date":67,"type":39},"2023-04-29",{"date":69,"type":21},"2026-01-30",{"name":45,"class":46},1,""]