[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03002272":3,"trial-entities:NCT03002272":84,"trial-summary:NCT03002272":87},{"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":23,"interventions":26,"primary_outcomes":36,"secondary_outcomes":41,"sex":50,"minimum_age":51,"maximum_age":21,"healthy_volunteers":14,"eligibility_criteria":52,"std_ages":56,"locations":59,"central_contacts":78,"overall_officials":81,"references":82,"see_also_links":83},"NCT03002272","TAVR Durability","Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study","RECRUITING","2028-01","2023-05","2023-05-26","2018-02-20","Medstar Health Research Institute","OTHER",false,"In this observational study, the investigators will enroll subjects who underwent TAVR or SAVR more than 3 years ago. Clinical and procedural data from the implant\u002Fsurgery will be collected, alongside clinical and echocardiographic data from subsequent follow-up visits.","There is limited available information on long term TAVR valve function. In this observational study, the investigators will enroll subjects who underwent TAVR or SAVR more than 3 years ago. Clinical and procedural data from the implant\u002Fsurgery will be collected, alongside clinical and echocardiographic data from subsequent follow-up visits. Up-to-date echocardiography will be performed and analyzed in a Core Lab to assess valve function yearly.",[18],"Aortic Valve Replacement",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},100,"ESTIMATED",[27,32],{"type":28,"name":29,"description":30,"armGroupLabels":31},"DEVICE","TAVR","subjects that underwent TAVR more than 3 years ago",[29],{"type":28,"name":33,"description":34,"armGroupLabels":35},"SAVR","Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago",[33],[37],{"measure":38,"description":39,"timeFrame":40},"Prosthetic valve dysfunction","Mean aortic valve gradient ≥20 mm Hg Moderate-severe transvalvular aortic regurgitation","7 years",[42,46],{"measure":43,"description":44,"timeFrame":45},"Change in functional status","Change in functional status from baseline and discharge per NYHA classification","discharge from hospital",{"measure":47,"description":48,"timeFrame":49},"Increase in severity of aortic regurgitation","Increase in severity of aortic regurgitation by one or more grading of severity","upto 7 years","ALL","18 Years",{"inclusion":53,"exclusion":54,"raw_text":55},[],[],"Inclusion criteria for TAVR subjects\n\na) TAVR performed more than 3 years ago\n\nExclusion criteria\n\n1. Subjects unable to consent to participate, unless the subject has a legally authorized representative\n2. Subjects unwilling to participate\n3. Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure)\n4. Echocardiographic evidence of prosthetic valve dysfunction within first 3 years post-TAVR (mean aortic gradient ≥20mmHg AND\u002FOR moderate-severe transvalvular aortic regurgitation)\n\nInclusion criteria for SAVR subjects\n\n1. SAVR performed more than 3 years ago\n2. Propensity matched to an enrolled TAVR subject\n\nExclusion criteria for SAVR subjects e) Subjects unable to consent to participate, unless the subject has a legally authorized representative f) Subjects unwilling to participate g) Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure) h) Echocardiographic evidence of prosthetic valve dysfunction within first 3 years post-SAVR (mean aortic gradient ≥20mmHg AND\u002FOR moderate-severe transvalvular aortic regurgitation)",[57,58],"ADULT","OLDER_ADULT",[60],{"facility":61,"status":7,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":75},"Washington Hospital Center","Washington D.C.","District of Columbia","20010","United States",[67,72],{"name":68,"role":69,"phone":70,"email":71},"Megan Rowland","CONTACT","202-877-2959","megan.e.rowland@medstar.net",{"name":73,"role":74},"Ron Waksman, MD","PRINCIPAL_INVESTIGATOR",{"lat":76,"lon":77},38.89511,-77.03637,[79],{"name":80,"role":69,"phone":70,"email":71},"Megan Rowland, MPH",[],[],[],{"nct_id":4,"conditions":85,"biomarkers":86},[18],[],{"nct_id":4,"found":88,"summary":89,"prompt_version":99},true,{"design":90,"status":91,"heading":92,"summary":93,"follow_up":94,"word_count":95,"commitments":96,"compensation":97,"drugs_mentioned":98},"This is an observational study with a planned enrollment of 100 participants. It compares subjects who underwent TAVR to historical controls who underwent SAVR.","completed","Long-term Follow-up of TAVR and SAVR for Aortic Valve Replacement","This study is looking at how well two types of aortic valve replacement procedures, TAVR (Transcatheter Aortic Valve Replacement) and SAVR (Surgical Aortic Valve Replacement), work over a long period. Researchers want to understand the long-term function of these prosthetic (artificial) valves. You might be able to join if you had a TAVR procedure more than three years ago. The study will collect information from your medical records and follow-up visits, including echocardiograms (ultrasound of the heart) to check valve function. The main goal is to see if there is any prosthetic valve dysfunction (problems with the artificial valve) after seven years. This is an observational study, meaning researchers will watch and collect information without giving new treatments. The current status of the study is unclear.","The primary endpoint, prosthetic valve dysfunction, is measured at 7 years.",126,"The study will collect clinical and procedural data from your original implant\u002Fsurgery, along with clinical and echocardiographic data from subsequent follow-up visits. Up-to-date echocardiography will be performed yearly.","Not stated in the trial record.",[29,33],"v2"]