Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-02 @ 3:13 AM
Study NCT ID:
NCT06924151
Status:
RECRUITING
Last Update Posted:
2025-08-28
First Post:
2025-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065467', 'term': 'Transcatheter Aortic Valve Replacement'}], 'ancestors': [{'id': 'D019918', 'term': 'Heart Valve Prosthesis Implantation'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2037-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2025-02-11', 'studyFirstSubmitQcDate': '2025-04-04', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'All cause mortality', 'timeFrame': 'at 30 days'}, {'measure': 'The rate of all stroke (disabling and nondisabling)', 'timeFrame': 'at 30 days'}, {'measure': 'The rate of Rehospitalization (valve-related or procedure-related and including heart failure)', 'timeFrame': 'at 30 days'}, {'measure': 'All cause mortality or all stroke', 'timeFrame': 'at one year'}, {'measure': 'All cause mortality or disabling stroke', 'timeFrame': 'at 30 days'}, {'measure': 'The rate of vascular complications (major)', 'timeFrame': 'at 30 days and one year'}, {'measure': 'The rate of Bleeding complications (life threatening, disabling or major)', 'timeFrame': 'at 30 days'}, {'measure': 'The rate of myocardial infarction', 'timeFrame': 'at 30 days and one year'}, {'measure': 'The rate of acute kidney injury', 'timeFrame': 'at 30 days'}, {'measure': 'the rate of new bundle branch block or new pacemaker implantation', 'timeFrame': 'at 30 days'}, {'measure': 'the rate of occurrence of perivalvular regurgitation ≥ mild by echocardiography', 'timeFrame': 'at 30 days'}, {'measure': 'The rate of coronary obstruction requiring intervention', 'timeFrame': 'at 30 days and one year'}, {'measure': 'New York Heart Association class', 'timeFrame': 'at 30 days and one year', 'description': 'NYHA Classification criteria:\n\nClass I: Subjects with cardiac disease but without resulting limitations of physical activity Class II: Subjects with cardiac disease resulting in slight limitation of physical activity Class III: Subjects with cardiac disease resulting in marked limitation of physical activity Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort'}, {'measure': 'Six-minute walk test', 'timeFrame': 'at 30 days and one year'}, {'measure': 'The length of postoperative ICU stay', 'timeFrame': 'up to one year'}, {'measure': 'Discharge location', 'timeFrame': 'up to one year', 'description': '* Home \\[including return to pre-admission facilities (excluding hospitals)\\]\n* Other hospital \\[excluding rehabilitation hospital\\]\n* Rehabilitation hospital\n* Death\n* Other'}, {'measure': 'Health status as evaluated by Quality of Life questionnaires (KCCQ)', 'timeFrame': 'at 30 days', 'description': 'The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.\n\nThis instrument was developed and validated by John Spertus. 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': 'Health status as evaluated by Quality of Life questionnaires (EQ-5D-5L)', 'timeFrame': 'at 30 days', 'description': 'EQ-5D-5L: Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state'}, {'measure': 'Cognitive function assessed by the MMSE', 'timeFrame': 'at one year', 'description': 'It is an 11-question measure that tests five areas of cognitive function:\n\norientation, registration, attention and calculation, recall, and language. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment.'}, {'measure': 'The rate of new onset atrial fibrillation', 'timeFrame': 'at one year'}, {'measure': 'Endpoints of minimally invasive aortic valve replacement (MICS AVR) vs TAVR', 'timeFrame': 'at 30 days and one year'}], 'primaryOutcomes': [{'measure': 'Composite endpoint of all-cause mortality, all stroke, and rehospitalization (valve-related or procedure-related and including heart failure)', 'timeFrame': 'at 1 year post procedure'}], 'secondaryOutcomes': [{'measure': 'the rate of all-cause mortality or disabling stroke', 'timeFrame': 'at one year'}, {'measure': 'the rate of all-cause mortality', 'timeFrame': 'at one year'}, {'measure': 'the rate of all stroke', 'timeFrame': 'at one year'}, {'measure': 'the rate of disabling stroke', 'timeFrame': 'at one year'}, {'measure': 'the rate of rehospitalization (valve-related or procedure-related and including heart failure)', 'timeFrame': 'at one year'}, {'measure': 'the rate of new bundle branch block or new pacemaker implantation', 'timeFrame': 'at one year'}, {'measure': 'the rate of new onset of atrial fibrillation', 'timeFrame': 'at 30 days'}, {'measure': 'the rate of life-threatening bleeding', 'timeFrame': 'at one year'}, {'measure': 'the rate of occurrence of perivalvular regurgitation ≥ mild by echocardiography', 'timeFrame': 'at one year'}, {'measure': 'Quality of life as assessed by KCCQ', 'timeFrame': 'at one year'}, {'measure': 'Quality of life as assessed by EQ-5D-5L', 'timeFrame': 'at one year'}, {'measure': 'the rate of prosthetic valve endocarditis', 'timeFrame': 'at one year'}, {'measure': 'the rate of prosthetic valve thrombosis', 'timeFrame': 'at one year'}, {'measure': 'the rate of valve-related dysfunction requiring repeat procedure', 'timeFrame': 'at one year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Stenosis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This study is the Prospective, Randomized, Controlled, Multi-center Study of Isolated SAVR in Low Risk AS Patients (The AMETHYST trial). Patients will be randomized 1:1 to receive either SAVR or transcatheter heart valve replacement (TAVR) with a commercially available surgical and transcatheter bioprosthetic valves. The aim of this study was to assess the non-inferiority of SAVR compared with TAVR for the combined endpoints of death from any cause, stroke and rehospitalization (hospitalization related to biological valves or procedures or heart failure) at 1 year postoperatively. Patients will be seen for follow-up visits at discharge, 30 days, and annually through 10 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "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/s or mean gradient ≥ 40 mmHg OR\n * AVA ≤1.0 cm2 or AVA index ≤ 0.6 cm2/m2 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 \\<50%\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 \\< 3000 cell/mL), Thrombocytopenia (Plt \\< 50,000 cell/mL), 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 \\< 30%\n18. Cardiac imaging (echo, CT, and/or MRI) evidence of intracardiac mass, thrombus or vegetation\n19. Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure\n20. Stroke or transient ischemic attack (TIA) within 90 days of randomization\n21. Renal insufficiency (eGFR \\< 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy\n22. Active bacterial endocarditis within 180 days of randomization\n23. Severe lung disease (FEV1 \\< 50% predicted) or currently on home oxygen\n24. Severe pulmonary hypertension (e.g., PA systolic pressure ≥ 2/3 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/m2\n29. Estimated life expectancy \\< 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"}, 'identificationModule': {'nctId': 'NCT06924151', 'acronym': 'AMETHYST', 'briefTitle': 'Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Osaka University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'AMETHYST-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surgical aortic valve replacement', 'description': "Surgical aortic valve replacement (SAVR) with free choice of surgical bioprosthesis and free choice of surgical access according to the surgeon's preference", 'interventionNames': ['Procedure: surgical aortic valve replacement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transcatheter aortic valve replacement', 'description': 'Transcatheter aortic valve replacement (TAVR) using the device available in Japan in facilities approved to perform TAVR.', 'interventionNames': ['Procedure: Transcatheter aortic valve replacement']}], 'interventions': [{'name': 'surgical aortic valve replacement', 'type': 'PROCEDURE', 'description': 'SAVR', 'armGroupLabels': ['Surgical aortic valve replacement']}, {'name': 'Transcatheter aortic valve replacement', 'type': 'PROCEDURE', 'description': 'TAVR', 'armGroupLabels': ['Transcatheter aortic valve replacement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4538511', 'city': 'Nagoya', 'state': 'Aichi-ken', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Masayoshi Tokoro, M.D.', 'role': 'CONTACT', 'email': 'm.tokoro0614@gmail.com', 'phone': '+81524815111'}, {'name': 'Masayoshi Tokoro, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Toshiaki Ito, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '2402232', 'city': 'Matsudo', 'state': 'Chiba', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Toru Naganuma, M.D.', 'role': 'CONTACT', 'email': 'data-management@shin-tokyohospital.or.jp', 'phone': '+81-47-711-8700'}, {'name': 'Toru Naganuma, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New Tokyo Hospital', 'geoPoint': {'lat': 35.77995, 'lon': 139.90144}}, {'zip': '2702251', 'city': 'Matsudo', 'state': 'Chiba', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yoshitsugu Nakamura, M.D.', 'role': 'CONTACT', 'email': 'ystgnkmr@gmail.com', 'phone': '+81473848111'}, {'name': 'Yoshitsugu Nakamura, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Taisuke Nakayama, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chibanishi General Hospital', 'geoPoint': {'lat': 35.77995, 'lon': 139.90144}}, {'zip': '2790001', 'city': 'Urayasu', 'state': 'Chiba', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Joji Ito, M.D.', 'role': 'CONTACT', 'email': 'jojiitocvs@gmail.com', 'phone': '+8147-351-3101'}, {'name': 'Joji Ito, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tokyo Bay Urayasu Ichikawa Medical Center', 'geoPoint': {'lat': 35.65879, 'lon': 139.90055}}, {'zip': '910-0833', 'city': 'Fukui-shi', 'state': 'Fukui', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Osamu Monta, M.D.', 'role': 'CONTACT', 'email': 'monta_fcvc@yahoo.co.jp', 'phone': '0776-54-5660'}, {'name': 'Osamu Monta, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fukui Cardiovascular center', 'geoPoint': {'lat': 36.06443, 'lon': 136.22257}}, {'zip': '8128582', 'city': 'Fukuoka', 'state': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Akira Shiose, M.D.', 'role': 'CONTACT', 'email': 'shiose.akira.799@m.kyushu-u.ac.jp', 'phone': '+81926411151'}, {'name': 'Akira Shiose, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hiromichi Sonoda, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kyushu Univerisity', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '802-8555', 'city': 'Kitakyushu', 'state': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Shinichi Shirai, M.D.', 'role': 'CONTACT', 'email': 'shirai440130@gmail.com', 'phone': '+81935112000'}, {'name': 'Shinichi Shirai, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nobuhisa Ono, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kokura Memorial Hospital', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'zip': '8300011', 'city': 'Kurume', 'state': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Tohru Takaseya, M.D.', 'role': 'CONTACT', 'email': 'ttakaseya@kurume-u.ac.jp', 'phone': '+81942353311'}, {'name': 'Tohru Takaseya, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Eiki Tayama, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kurume University', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}, {'zip': '6638501', 'city': 'Nishinomiya', 'state': 'Hyōgo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kenichi Watanabe, M.D.', 'role': 'CONTACT', 'email': 'kenichi217@yahoo.co.jp', 'phone': '+817989456111'}, {'name': 'Kenichi Watanabe, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Taichi Sakaguchi, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hyogo Medical University', 'geoPoint': {'lat': 34.71562, 'lon': 135.33199}}, {'zip': '8920853', 'city': 'Kagoshima', 'state': 'Kagoshima-ken', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Naoki Tateishi, M.D.', 'role': 'CONTACT', 'email': 'tateishi123123@gmail.com', 'phone': '+81992231151'}, {'name': 'Naoki Tateishi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kagoshima Medical Center', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '2591193', 'city': 'Isehara', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yohei Ohno, M.D.', 'role': 'CONTACT', 'email': 'yohno@tokai.ac.jp', 'phone': '+81463931121'}, {'name': 'Yohei Ohno, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yasunori Cho, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tokai University', 'geoPoint': {'lat': 35.39932, 'lon': 139.31019}}, {'zip': '2478533', 'city': 'Kamakura', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Shigeru Saito, M.D.', 'role': 'CONTACT', 'email': 'transradial@kamakuraheart.org', 'phone': '+81467461717'}, {'name': 'Shigeru Saito, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tohru Asai, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Shonan Kamakura General Hospital', 'geoPoint': {'lat': 35.31085, 'lon': 139.54698}}, {'zip': '2120014', 'city': 'Kawasaki', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Shuichiro Takanashi, M.D.', 'role': 'CONTACT', 'email': 's0715t@gmail.com', 'phone': '+81445444611'}, {'name': 'Shuichiro Takanashi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Takayuki Kawamura, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kawasakisaiwai Hospital', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'zip': '2168511', 'city': 'Kawasaki', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kan Nawata, M.D.', 'role': 'CONTACT', 'email': 'kan.nawata@marianna-u.ac.jp', 'phone': '+81449778111'}, {'name': 'Kan Nawata, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Masaki Izumo, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'St.Marianna University School of Medicine', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'zip': '7808522', 'city': 'Kochi', 'state': 'Kochi', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hiroyuki Irie, M.D.', 'role': 'CONTACT', 'email': 'irie@chikamori.com', 'phone': '+81888225231'}, {'name': 'Hiroyuki Irie, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kazuya Kawai, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chikamori Hospital', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'zip': '8608556', 'city': 'Kumamoto', 'state': 'Kumamoto', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kenichi Tsujita, M.D.', 'role': 'CONTACT', 'email': 'tsujita@kumamoto-u.ac.jp', 'phone': '+81963735025'}, {'name': 'Kenichi Tsujita, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Toshihiro Fukui, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kumamoto University', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '3908621', 'city': 'Matsumoto', 'state': 'Nagano', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Tatsuichiro Seto, M.D.', 'role': 'CONTACT', 'email': 'seto@shinshu-u.ac.jp', 'phone': '+81570003010'}, {'name': 'Tatsuichiro Seto, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Haruki Tanaka, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Shinshu University', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}, {'zip': '8528501', 'city': 'Nagasaki', 'state': 'Nagasaki', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Takashi Miura, M.D.', 'role': 'CONTACT', 'email': 'takashirsa@nagasaki-u.ac.jp', 'phone': '+81958197200'}, {'name': 'Takashi Miura, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Koji Maemura, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Nagasaki University', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'zip': '951-8520', 'city': 'Niigata', 'state': 'Niigata', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Keitaro Domae, M.D.', 'role': 'CONTACT', 'email': 'minipoooooh@yahoo.co.jp', 'phone': '025-223-6161'}, {'name': 'Keitaro Domae, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Niigata University Medical and Dental Hospital', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'zip': '7000804', 'city': 'Okayama', 'state': 'Okayama-ken', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Arudo Hiraoka, M.D.', 'role': 'CONTACT', 'email': 'bassbord1028@yahoo.co.jp', 'phone': '81862257111'}, {'name': 'Arudo Hiraoka, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hidenori Yoshitaka, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Sakakibara Heart Institute of Okayama', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '9010224', 'city': 'Tomigusuku', 'state': 'Okinawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Akihiko Yamauchi', 'role': 'CONTACT', 'email': 'yamauchi4964@gmail.com', 'phone': '0988503811'}, {'name': 'Akihiko Yamauchi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yuuai Medical Center', 'geoPoint': {'lat': 26.18583, 'lon': 127.68192}}, {'zip': '5960042', 'city': 'Kishiwada', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Satoshi Kuroyanagi, M.D.', 'role': 'CONTACT', 'email': 'satoshi_5023@yahoo.co.jp', 'phone': '+81724459915'}, {'name': 'Satoshi Kuroyanagi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kishiwada Tokusyukai Hospital', 'geoPoint': {'lat': 34.46667, 'lon': 135.36667}}, {'zip': '5438922', 'city': 'Osaka', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yoshiki Sawa, M.D.', 'role': 'CONTACT', 'email': 'yshksw2@gmail.com', 'phone': '+81667716051'}, {'name': 'Yoshiki Sawa, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yasuhiro Ichibori, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Osaka International Medical and Science Center', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '558-8558', 'city': 'Osaka', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Naosumi Sekiya, M.D.', 'role': 'CONTACT', 'email': 'sekiyan73@gmail.com', 'phone': '06-6692-1201'}, {'name': 'Naosumi Sekiya, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Atsushi 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