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John is Director of Cardiovascular Education and Outcomes Research at the Mid America Heart Institute, and he is also a Professor of Medicine at the University of Missouri - Kansas City.\n\nIn the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. For brevity, only the performance characteristics of the overall summary score are presented in this discussion.",{"measure":83,"description":84,"timeFrame":29},"Health status as evaluated by Quality of Life questionnaires (EQ-5D-5L)","EQ-5D-5L: Measures 5 domains (mobility, self-care, usual activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression) that can be converted to utilities using an algorithm. 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University","Kumamoto","8608556",{"type":139,"coordinates":563},[564,565],130.69181,32.80589,{"lat":565,"lon":564},[568,572,573],{"name":569,"role":124,"phone":570,"phoneExt":11,"email":571},"Kenichi Tsujita, M.D.","+81963735025","tsujita@kumamoto-u.ac.jp",{"name":569,"role":150,"phone":11,"phoneExt":11,"email":11},{"name":574,"role":165,"phone":11,"phoneExt":11,"email":11},"Toshihiro Fukui, M.D.",{"facility":576,"status":132,"city":577,"state":11,"zip":578,"country":136,"countryCode":137,"cosmosGeoPoint":579,"geoPoint":583,"contacts":584},"Nagasaki University","Nagasaki","8528501",{"type":139,"coordinates":580},[581,582],129.88333,32.75,{"lat":582,"lon":581},[585,589,590],{"name":586,"role":124,"phone":587,"phoneExt":11,"email":588},"Takashi Miura, M.D.","+81958197200","takashirsa@nagasaki-u.ac.jp",{"name":586,"role":150,"phone":11,"phoneExt":11,"email":11},{"name":591,"role":165,"phone":11,"phoneExt":11,"email":11},"Koji Maemura, M.D.",{"facility":593,"status":132,"city":594,"state":11,"zip":595,"country":136,"countryCode":137,"cosmosGeoPoint":596,"geoPoint":600,"contacts":601},"Niigata University Medical and Dental Hospital","Niigata","951-8520",{"type":139,"coordinates":597},[598,599],139.04125,37.92259,{"lat":599,"lon":598},[602,606],{"name":603,"role":124,"phone":604,"phoneExt":11,"email":605},"Makoto Hoyano, M.D.","025-223-6161","mhoyano@med.niigata-u.ac.jp",{"name":603,"role":150,"phone":11,"phoneExt":11,"email":11},{"facility":608,"status":132,"city":609,"state":11,"zip":610,"country":136,"countryCode":137,"cosmosGeoPoint":611,"geoPoint":615,"contacts":616},"The Sakakibara Heart Institute of Okayama","Okayama","7000804",{"type":139,"coordinates":612},[613,614],133.93333,34.65,{"lat":614,"lon":613},[617,621,622],{"name":618,"role":124,"phone":619,"phoneExt":11,"email":620},"Arudo Hiraoka, M.D.","81862257111","bassbord1028@yahoo.co.jp",{"name":618,"role":150,"phone":11,"phoneExt":11,"email":11},{"name":623,"role":165,"phone":11,"phoneExt":11,"email":11},"Hidenori Yoshitaka, M.D.",{"facility":625,"status":132,"city":338,"state":11,"zip":626,"country":136,"countryCode":137,"cosmosGeoPoint":627,"geoPoint":631,"contacts":632},"Osaka International Medical and Science Center","5438922",{"type":139,"coordinates":628},[629,630],135.50107,34.69379,{"lat":630,"lon":629},[633,637,638],{"name":634,"role":124,"phone":635,"phoneExt":11,"email":636},"Yoshiki Sawa, M.D.","+81667716051","yshksw2@gmail.com",{"name":634,"role":150,"phone":11,"phoneExt":11,"email":11},{"name":639,"role":165,"phone":11,"phoneExt":11,"email":11},"Yasuhiro Ichibori, M.D.",{"facility":641,"status":132,"city":338,"state":11,"zip":642,"country":136,"countryCode":137,"cosmosGeoPoint":643,"geoPoint":645,"contacts":646},"Osaka General Medical Center","558-8558",{"type":139,"coordinates":644},[629,630],{"lat":630,"lon":629},[647,651,652],{"name":648,"role":124,"phone":649,"phoneExt":11,"email":650},"Naosumi Sekiya, M.D.","06-6692-1201","sekiyan73@gmail.com",{"name":648,"role":150,"phone":11,"phoneExt":11,"email":11},{"name":653,"role":165,"phone":11,"phoneExt":11,"email":11},"Atsushi Kikuchi, M.D.",{"facility":655,"status":132,"city":338,"state":11,"zip":11,"country":136,"countryCode":137,"cosmosGeoPoint":656,"geoPoint":658,"contacts":659},"National Hospital Organization Osaka National Hospital",{"type":139,"coordinates":657},[629,630],{"lat":630,"lon":629},[660,664],{"name":661,"role":124,"phone":662,"phoneExt":11,"email":663},"Tetsuya Saito, M.D.","81-6-6942-1331","saito.tetsuya.nj@mail.hosp.go.jp",{"name":661,"role":150,"phone":11,"phoneExt":11,"email":11},{"facility":666,"status":132,"city":402,"state":11,"zip":667,"country":136,"countryCode":137,"cosmosGeoPoint":668,"geoPoint":672,"contacts":673},"Shizuoka General Hospital","4208527",{"type":139,"coordinates":669},[670,671],138.38333,34.98333,{"lat":671,"lon":670},[674,678],{"name":675,"role":124,"phone":676,"phoneExt":11,"email":677},"Hiroshi Tsuneyoshi, M.D.","+8154-247-6111","tuneyosi_ca@yahoo.co.jp",{"name":675,"role":150,"phone":11,"phoneExt":11,"email":11},{"facility":680,"status":132,"city":681,"state":11,"zip":11,"country":136,"countryCode":137,"cosmosGeoPoint":682,"geoPoint":686,"contacts":687},"National cerebral and cardiovascular center","Suita",{"type":139,"coordinates":683},[684,685],135.51567,34.76143,{"lat":685,"lon":684},[688,692],{"name":689,"role":124,"phone":690,"phoneExt":11,"email":691},"Satsuki Fukushima, M.D.","81-6-6170-1070","s.fukushima@ncvc.go.jp",{"name":689,"role":150,"phone":11,"phoneExt":11,"email":11},{"facility":694,"status":132,"city":695,"state":11,"zip":696,"country":136,"countryCode":137,"cosmosGeoPoint":697,"geoPoint":701,"contacts":702},"Tokushima University","Tokushima","7708503",{"type":139,"coordinates":698},[699,700],134.56667,34.06667,{"lat":700,"lon":699},[703,707],{"name":704,"role":124,"phone":705,"phoneExt":11,"email":706},"Hiroki Hata, M.D.","+8188-631-3111","hatahiro@tokushima-u.ac.jp",{"name":704,"role":150,"phone":11,"phoneExt":11,"email":11},{"facility":709,"status":132,"city":710,"state":11,"zip":711,"country":136,"countryCode":137,"cosmosGeoPoint":712,"geoPoint":716,"contacts":717},"Wakayama Medical University","Wakayama","6418509",{"type":139,"coordinates":713},[714,715],135.16667,34.23333,{"lat":715,"lon":714},[718,722,723],{"name":719,"role":124,"phone":720,"phoneExt":11,"email":721},"Kentaro Honda, M.D.","+81734472300","honda-k@wakayama-med.ac.jp",{"name":719,"role":150,"phone":11,"phoneExt":11,"email":11},{"name":724,"role":165,"phone":11,"phoneExt":11,"email":11},"Teruaki Wada, M.D.",{"type":726,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100587112","isolated-surgical-aortic-valve-replacement-in-low-risk-as-patients-100587112",false,"NCT06924151","Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients","the Prospective, Randomized, Controlled, Multi-center Study to Establish the Safety and Effectiveness of Isolated Surgical Aortic Valve Replacement in Low Risk Patients Who Have Symptomatic Severe Aortic Stenosis","AMETHYST","Inclusion Criteria:\n\n1. All study participants must meet the following inclusion criteria 1. Severe, calcific aortic stenosis with the following criteria:\n\n   * Jet velocity ≥4.0 m\u002Fs or mean gradient ≥ 40 mmHg OR\n   * AVA ≤1.0 cm2 or AVA index ≤ 0.6 cm2\u002Fm2 Note: Qualifying TTE must be within 90 days prior to randomization\n\n   AND 2. NYHA class ≥ II OR Exercisee test that demonstrates a limited exercise capacity, abnormal blood pressure response, or arrhythmia OR Asymptomatic patients with LVEF \\\u003C50%\n2. The Heart Team agrees that the surgical mortality risk is less than 4% according to STS-PROM. The Heart Team's assessment should include evaluation of overall clinical status and comorbidities that may not be adequately captured by risk calculators such as STS-PROM, in addition to the risk score itself.\n3. The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by certified review board.\n\nExclusion Criteria:\n\nCandidates will be excluded from the study if any of the following conditions are present:\n\n1. History of cardiovascular surgery or thoracotomy\n2. Pre-existing other valvular disease, coronary artery disease or aortic disease required intervention Note: interventions for arrhythmia or root enlargement are not considered exclusionary.\n3. Heart Team assessment that chest abnormalities or significant frailty would prevent safe SAVR.\n4. Native aortic annulus size unsuitable for sizes the currently approved and marketed SAVR or TAVR based on preoperative 3D-CT image analysis.\n5. Iliofemoral vessel characteristics that whould preclude safe insertion of the introducer sheath.\n6. Evidence of an acute myocardial infarction or PCI ≤ 30 days before randomization\n7. Aortic valve is unicuspid\n8. Severe aortic regurgitation (\\>3+)\n9. Severe mitral regurgitation (\\>3+) or ≥ moderate stenosis\n10. Severe tricuspid regurgitation (\\>3+) or ≥ moderate stenosis\n11. Pre-existing mechanical or bioprosthetic valve in any position.\n12. Complex coronary artery disease:\n\n    1. Heart Team assessment that CABG is recommended at the time of SAVR\n    2. Heart Team assessment that optimal revascularization cannot be performed\n13. Symptomatic carotid or vertebral artery disease or treatment of carotid stenosis within 30 days of randomization\n14. Leukopenia (WBC \\\u003C 3000 cell\u002FmL), Thrombocytopenia (Plt \\\u003C 50,000 cell\u002FmL), history of bleeding diathesis or coagulopathy.\n15. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization\n16. Hypertrophic cardiomyopathy with obstruction (HOCM)\n17. Ventricular dysfunction with LVEF \\\u003C 30%\n18. Cardiac imaging (echo, CT, and\u002For MRI) evidence of intracardiac mass, thrombus or vegetation\n19. Inability to tolerate or condition precluding treatment with antithrombotic\u002Fanticoagulation therapy during or after the valve implant procedure\n20. Stroke or transient ischemic attack (TIA) within 90 days of randomization\n21. Renal insufficiency (eGFR \\\u003C 30 ml\u002Fmin per the Cockcroft-Gault formula) and\u002For renal replacement therapy\n22. Active bacterial endocarditis within 180 days of randomization\n23. Severe lung disease (FEV1 \\\u003C 50% predicted) or currently on home oxygen\n24. Severe pulmonary hypertension (e.g., PA systolic pressure ≥ 2\u002F3 systemic pressure)\n25. History of cirrhosis or active liver disease\n26. Significant abdominal or thoracic aortic disease (such as porcelain aorta, aneurysm, severe calcification, aortic coarctation, etc.) that would preclude cannulation and aortotomy for SAVR or safe passage of the delivery system for TAVR.\n27. Patient refuses blood products.\n28. BMI \\> 50 kg\u002Fm2\n29. Estimated life expectancy \\\u003C 24 months.\n30. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication.\n31. Immobility or significant cognitive impairment that would prevent completion of study procedure.\n32. Currently participating in an investigational drug or another device study.\n33. Unsuitable as candidates by the principal investigator or a research associate for other reasons","ALL",{"count":737,"type":738},450,"ESTIMATED","INTERVENTIONAL",[741],"NA","To establish the safety and effectiveness of surgical aortic valve replacement (SAVR) in patients with isolated severe, calcific aortic stenosis who are at low surgical risk.",[744],"Aortic Stenosis","2026-09-03",{"date":747,"type":748},"2026-09-04","ACTUAL",{"date":750,"type":748},"2025-06-01",{"date":752,"type":738},"2040-05-31",{"name":5,"class":6},37]