[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Third People's Hospital of Chengdu\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":199},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,51,79,102,125,156,176],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100616098","fih-study-of-pflotus-in-persistent-atrial-fibrillation-100616098",false,"NCT07301190","FIH Study of PFLotus in Persistent Atrial Fibrillation","First-in-Human Experience Using a Novel Shape-Adaptive Pulsed Field Ablation Catheter in Persistent Atrial Fibrillation","PFLotus- FIH","Inclusion Criteria:\n\n1\\. Aged between 18 and 75 years (inclusive), regardless of gender 2. Diagnosed with symptomatic persistent atrial fibrillation (AF). The patient's medical records document that the duration of AF episodes exceeds 7 days or the patient has a history of persistent AF, and meets \\*\\*any one\\*\\* of the following criteria:\n\n1. A 24-hour ambulatory electrocardiogram (Holter) recorded within 365 days prior to enrollment shows AF throughout the monitoring period.\n2. Two electrocardiograms (ECGs) obtained at an interval of more than 7 days within 365 days prior to enrollment both demonstrate AF.\n\n3\\. Poor response to treatment with at least one class I or class III antiarrhythmic drug (AAD), or intolerance to class I or class III AADs.\n\n4\\. Willing to participate in the trial, comply with the follow-up requirements specified in the protocol, and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Paroxysmal atrial fibrillation (AF)\n2. AF caused by electrolyte disorders, thyroid diseases, or reversible\u002Fnon-cardiac etiologies\n3. Patients undergoing retreatment after ablation for rapid atrial tachyarrhythmias\n4. Patients with sustained ventricular tachycardia or ventricular fibrillation\n5. Left atrial anteroposterior diameter \\> 55 mm\n6. Pulmonary vein (PV) stenosis (\\>70%) or prior PV stent implantation\n7. History of left atrial ablation or cardiac surgery (including left atrial appendage closure)\n8. Implantation of permanent pacemaker, biventricular pacemaker, loop recorder\u002Finsertable cardiac monitor (ICM), or any type of implantable cardioverter-defibrillator (with or without biventricular pacing function)\n9. Contraindications to anticoagulation, or history of coagulation or bleeding abnormalities\n10. Severe pulmonary disease: severe pulmonary arterial hypertension or any pulmonary disease with severe dyspnea involving blood gas abnormalities\n11. Any of the following cardiac surgeries, implants, or conditions:\n\n    * Prosthetic heart valve\n    * NYHA Class III or IV congestive heart failure, or left ventricular ejection fraction (LVEF) \\\u003C 40%\n    * Atrial septal defect or ventricular septal defect closure\n    * Atrial myxoma, left atrial appendage device implantation or occlusion\n12. History of any of the following within 3 months prior to the procedure:\n\n    * Myocardial infarction\n    * Unstable angina\n    * Percutaneous coronary intervention\n    * Cardiac surgery (including coronary artery bypass grafting)\n    * Hospitalization for heart failure\n    * Pericarditis\n13. History of any of the following within 3 months prior to the procedure:\n\n    * Cerebral infarction or transient ischemic attack (TIA)\n    * Documented thromboembolic events (e.g., confirmed by transesophageal echocardiography \\[TEE\\])\n14. History of malignant tumor or expected life expectancy \\\u003C 12 months\n15. Mental disorders or history of mental illness with inability to cooperate independently\n16. Lactating, pregnant, or women planning or potentially becoming pregnant\n17. Acute or severe systemic infection, or significant abnormalities in liver\u002Frenal function\n18. Participation in other interventional clinical trials, or ineligibility for enrollment as judged by the investigator","ALL","18 Years","75 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"NA","Single-shot pulsed-field ablation (PFA) catheters maximize pulmonary vein isolation (PVI) efficiency but are limited for focal or linear ablation. The goal of this clinical trial is to evaluate the safety and effectiveness of a novel, PFA catheter that transitions between large 'petals' (single-shot), and a small, spherical 'bud' (large-focal\u002Flinear), enabling a PVI-plus strategy in patients with persistent AF (PersAF).\n\nThe main questions it aims to answer are:\n\n1. Is there an absence of serious procedure or device-related adverse events within 7 days?\n2. Can the catheter achieve durable lesions?\n\nThis trial enrolled patients with perAF , who were treated under general anesthesia with the shape-adaptive PFA catheter (PFLotus, bipolar, biphasic, 850 V, 60 μs, EnChannel Medical).\n\nParticipants will:\n\n1. Undergo PVI and linear ablation with the PFLotus PFA catheter under general anesthesia;\n2. Undergo remapping within 3-month post the index ablation to assess the durability of the lesions;\n3. Undergo follow-up occurred at 7 days, 30 days, 3, 6, and 12 months. Recurrence was assessed via 12-lead ECG at each visit and 24-hour or 7-day Holter monitoring at 6 and 12 months.",[28],"Persistent Atrial Fibrillation",[30,31,32,33,34,35,36,37],"persistent atrial fibrillation","pulmonary vein isolation","ablation time","procedure time","freedom from atrial tachyarrhythmia recurrence","cavotricuspid isthmus ablation","mitral isthmus ablation","coronary sinus","RECRUITING","2025-12-23",{"date":41,"type":42},"2025-12-24","ACTUAL",{"date":44,"type":42},"2025-06-11",{"date":46,"type":22},"2027-04-15",{"name":48,"class":49},"The Third People's Hospital of Chengdu","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":76,"leadSponsor":78,"locationsCount":4},"100617621","pflotus-with-the-depolar-mapping-system-in-patients-with-persistent-atrial-fibrillation-100617621","NCT07321002","PFLotus With the DePolar Mapping System in Patients With Persistent Atrial Fibrillation","Assessment of a Novel Shape-Adaptive Catheter With for Both Single-Shot and Large-Focal Pulsed Field Ablation the DePolar Mapping System in Persistent Atrial Fibrillation","Inclusion Criteria:\n\n1\\. Aged 18-75 years (inclusive). 2. Diagnosis of symptomatic persistent atrial fibrillation (AF), defined as documented AF episodes exceeding 7 days or a documented history of persistent AF. Additionally, at least one of the following criteria must be met within 365 days prior to enrollment:\n\n1. A 24-hour ambulatory ECG (Holter) recording demonstrating AF throughout the entire monitoring period.\n2. Two separate standard 12-lead ECGs, taken at least 7 days apart, both confirming AF.\n\n3\\. Documented failure or intolerance to at least one Class I or Class III antiarrhythmic drug (AAD).\n\n4\\. Willingness to participate in the trial, ability to comply with protocol-specified follow-up assessments, and provision of written informed consent.\n\nExclusion Criteria:\n\n1. Paroxysmal atrial fibrillation (AF)；\n2. AF caused by electrolyte disorders, thyroid diseases, or reversible\u002Fnon-cardiac etiologies；\n3. Patients undergoing retreatment after ablation for rapid atrial tachyarrhythmias；\n4. Patients with sustained ventricular tachycardia or ventricular fibrillation；\n5. Left atrial anteroposterior diameter \\> 55 mm；\n6. Pulmonary vein (PV) stenosis (\\>70%) or prior PV stent implantation；\n7. History of left atrial ablation or cardiac surgery (including left atrial appendage closure)；\n8. Implantation of permanent pacemaker, biventricular pacemaker, loop recorder\u002Finsertable cardiac monitor (ICM), or any type of implantable cardioverter-defibrillator (with or without biventricular pacing function)；\n9. Contraindications to anticoagulation, or history of coagulation or bleeding abnormalities；\n10. Severe pulmonary disease: severe pulmonary arterial hypertension or any pulmonary disease with severe dyspnea involving blood gas abnormalities；\n11. Any of the following cardiac surgeries, implants, or conditions:\n\n    * Prosthetic heart valve\n    * NYHA Class III or IV congestive heart failure, or left ventricular ejection fraction (LVEF) \\\u003C 40%\n    * Atrial septal defect or ventricular septal defect closure\n    * Atrial myxoma, left atrial appendage device implantation or occlusion\n12. History of any of the following within 3 months prior to the procedure:\n\n    * Myocardial infarction\n    * Unstable angina\n    * Percutaneous coronary intervention\n    * Cardiac surgery (including coronary artery bypass grafting)\n    * Hospitalization for heart failure\n    * Pericarditis\n13. History of any of the following within 3 months prior to the procedure:\n\n    * Cerebral infarction or transient ischemic attack (TIA)\n    * Documented thromboembolic events (e.g., confirmed by transesophageal echocardiography \\[TEE\\])\n14. History of malignant tumor or expected life expectancy \\\u003C 12 months；\n15. Mental disorders or history of mental illness with inability to cooperate independently；\n16. Lactating, pregnant, or women planning or potentially becoming pregnant；\n17. Acute or severe systemic infection, or significant abnormalities in liver\u002Frenal function；\n18. Participation in other interventional clinical trials, or ineligibility for enrollment as judged by the investigator.",{"count":59,"type":22},35,[25],"This clinical trial aims to evaluate the safety and efficacy of pulmonary vein isolation (PVI), focal, and linear ablation in patients with persistent atrial fibrillation (PersAF) using a novel shape-adaptive pulsed field ablation (PFA) catheter (PFLotus, EnChannel Medical) integrated with a novel mapping system (DePolar, EnChannel Medical).\n\nThe primary study objectives are to determine:\n\n* The incidence of serious procedure- or device-related adverse events within 7 days post-procedure (primary safety endpoint).\n* The clinical effectiveness of the integrated PFA and mapping system.\n* The ability of the novel PFA system to produce durable ablation lesions.\n\nPersAF patients will be treated under general anesthesia using the PFLotus PFA catheter (bipolar, biphasic waveform; 850 V, 60 μs per pulse). Ablation targets, including PVI and other lesions (left atrial posterior wall, mitral isthmus, cavotricuspid isthmus, and superior vena cava), will be accessed under fluoroscopic and DePolar mapping system guidance.\n\nParticipants will:\n\n1. Receive PVI, focal, and linear ablation using the PFLotus PFA catheter and DePolar mapping system under general anesthesia;\n2. Be monitored for serious procedure- or device-related adverse events during the first 7 days post-procedure;\n3. Undergo repeat electrophysiological mapping at 3 months to assess lesion durability;\n4. Attend scheduled follow-up visits at 7 days, 30 days, and 3, 6, and 12 months post-ablation. Atrial arrhythmia recurrence will be assessed via 12-lead electrocardiography at each visit and by 24-hour or 7-day Holter monitoring at the 6- and 12-month visits.",[28],[30,64,65,66,67,68,69,37,70],"pulse field ablation","pulmonary vein isolaiton","left atrial posterior wall","mitral isthmus isolaiton","cavotricuspid isthmus isolation","superior vena cava","epicardial ablation","NOT_YET_RECRUITING","2025-12-22",{"date":74,"type":42},"2026-01-06",{"date":72,"type":22},{"date":77,"type":22},"2027-07-31",{"name":48,"class":49},{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":86,"enrollmentInfo":87,"targetDuration":89,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":50},"100571477","assessment-of-fibbroscan-in-diagnosing-masld-among-the-chinese-population-with-obesity-100571477","NCT06720766","Assessment of FibbroScan in Diagnosing MASLD Among the Chinese Population With Obesity","MASLD","Inclusion Criteria:\n\n1. Patients aged 18 years or older who provided written informed consent\n2. Patients who schedule to undergo bariatric surgery and a liver biopsy (LB) for the investigation of suspected MASLD\n3. Patients who schedule to undergo FibroScan examination\n\nExclusion Criteria:\n\n1. Patients with ascites or pregnant women\n2. Patients with any active implantable medical device (such as a pacemaker or defibrillator)\n3. Patients who have undergone liver transplantation\n4. Patients with cardiac failure and\u002For significant valvular disease\n5. Patients with haemochromatosis\n6. Patients who have refused to undergo LB or blood tests\n7. Patients with a confirmed diagnosis of active malignancy, or other terminal disease\n8. Patients participating in another clinical trial within the preceding 30 days","70 Years",{"count":88,"type":22},600,"1 Month","OBSERVATIONAL","The non-invasive evaluation of liver steatosis and fibrosis with FibroScan is a routinely procedure in clinical practice for people with obesity. However, there are still considerable uncertainties regarding the potential influence of confounding factors and the optimal application of cut-off values for obesity.\n\nThe goal of this observational study is to learn about the optimal application of cut-off values of for Chinese people with obesity.",[93],"Fatty Liver Disease","2024-12-02",{"date":96,"type":42},"2024-12-06",{"date":98,"type":42},"2023-10-24",{"date":100,"type":22},"2025-03-31",{"name":48,"class":49},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":4},"100569832","clinical-study-on-the-risk-of-left-atrial-pop-ablation-and-esophageal-injury-under-ultra-high-power-and-related-influencing-parameters-100569832","NCT06699368","Clinical Study on the Risk of Left Atrial POP Ablation and Esophageal Injury Under Ultra-High Power and Related Influencing Parameters","UHP-POP-ESO","Inclusion Criteria:\n\n1. Patients aged between 18 and 80 years old.\n2. Diagnosed with drug-refractory, symptomatic, paroxysmal atrial fibrillation.\n3. Non-valvular atrial fibrillation.\n4. Able to understand the purpose of the study, voluntarily participate in this research, and the patient or their legal representative signs the informed consent form, willing to complete follow-ups as required by the protocol.\n\nExclusion Criteria:\n\n1. Atrial fibrillation secondary to thyroid disease or other reversible factors;\n2. Imaging studies indicating intracardiac thrombus;\n3. Moderate to severe mitral stenosis or regurgitation;\n4. Left ventricular ejection fraction \\\u003C40%, or New York Heart Association (NYHA) functional class III or IV;\n5. Unstable angina;\n6. Myocardial infarction (MI) or coronary artery bypass grafting (CABG) within 3 months prior to enrollment;\n7. Presence of mural thrombus, space-occupying disease, or other abnormalities that hinder vascular puncture or catheter manipulation;\n8. Contraindications to anticoagulation and a history of blood coagulation or bleeding abnormalities;\n9. Patients with active systemic infections; Patients who have had an atrial septal closure device implanted within the last 6 weeks;\n10. Female patients who are pregnant, breastfeeding, or unable to use contraception during the study period;\n11. Patients with a life expectancy of less than 12 months (e.g., advanced malignant tumors); patients who have had an atrial septal closure device implanted within the last 6 weeks;\n12. Conditions affecting vascular access;\n13. Patients who are concurrently participating in other drug or device clinical trials;\n14. Any other abnormalities or diseases that the investigator deems should exclude the patient from the study enrollment.","85 Years",{"count":111,"type":22},120,[25],"This study aims to evaluate the risks of steam pop (POP) and esophageal injury, as well as related influencing parameters, under ultra-high power ablation technology. In the treatment of arrhythmias such as atrial fibrillation, cardiac ablation surgery is a common method. The use of ultra-high power ablation technology can shorten the operation time and improve effectiveness, but it may also increase the risk of damage to surrounding structures such as the esophagus. We will recruit a certain number of patients who are scheduled to undergo ultra-high power ablation surgery. We will record various parameters during the surgery, such as energy, time, and contact force, and monitor patients for signs of esophageal injury after the surgery. We expect that through this study, we can better understand the potential risks of ultra-high power ablation to the esophagus and identify the key parameters affecting these risks. This will help to improve surgical techniques, reduce complications, and enhance patient safety and surgical outcomes.",[115],"Ultra-High Power Ablation,Safety of Atrial Fibrillation Ablation",[115],"2024-11-19",{"date":119,"type":42},"2024-11-21",{"date":121,"type":22},"2024-11-28",{"date":123,"type":22},"2025-06-05",{"name":48,"class":49},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":23,"phases":135,"briefSummary":136,"conditions":137,"keywords":141,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},"100566251","evaluating-the-safety-and-effectiveness-of-5g-cloud-follow-up-for-cardiovascular-implantable-electronic-devices-100566251","NCT06652750","Evaluating the Safety and Effectiveness of 5G Cloud Follow-up for Cardiovascular Implantable Electronic Devices","Evaluating the Safety and Effectiveness of 5G Cloud Follow-up for Cardiovascular Implantable Electronic Devices: a Prospective, Paired, Self-controlled, Non-inferiority, Multicenter Clinical Trial","CIED-CARE","Inclusion Criteria:\n\n1. Age ≥ 18 years, gender unspecified;\n2. Patients who have not undergone their first clinic follow-up after the implantation of cardiovascular implantable electronic devices (CIED); Note: In this study, CIED includes pacemakers, implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy pacemakers (CRT-P) and defibrillators (CRT-D), excluding implantable cardiac event recorders (ICM) and implantable cardiovascular monitors.\n3. Willing to participate in this clinical study and have signed the informed consent form in writing.\n\nExclusion Criteria:\n\n* Exclusion Criteria:\n\nIf meeting any of the following, the individual cannot be included:\n\n1. Life expectancy \\\u003C 1 year.\n2. Inability to cooperate with treatment or follow-up, such as having mental illness.\n3. Participated in other clinical studies within 30 days before enrollment. Other situations that the researcher deems unsuitable for inclusion.",{"count":134,"type":22},688,[25],"Objective: This clinical study employs a prospective, paired, self-controlled, non-inferiority, multicenter research design to assess the safety and efficacy of utilizing 5G cloud follow-up for CIED in parameters monitoring and remote programming post-implantation.\n\nParticipants will:\n\nundergo regular clinic follow-up visits in accordance with the guidelines undergo routine in-office follow-up and 5G cloud follow-up during each regular clinic visit",[138,139,140],"Sick Sinus Syndrome","Atrioventricular Block, Second and Third Degree","Heart Failure",[142,143,144,145,146,147],"pacemaker","implantable cardioverter defibrillator","cardiac resynchronization therapy","follow up","remote programming","in-office follow-up","2024-11-18",{"date":119,"type":42},{"date":151,"type":42},"2024-11-13",{"date":153,"type":22},"2026-02-01",{"name":48,"class":49},2,{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":164,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":173,"leadSponsor":175,"locationsCount":4},"100569466","a-study-on-the-relationship-between-individualized-low-voltage-regions-in-left-atrium-and-the-mechanism-of-atrial-fibrillation-in-persistent-atrial-fibrillation-under-ultra-high-resolution-mapping-100569466","NCT06694610","A Study on the Relationship Between Individualized Low Voltage Regions in Left Atrium and the Mechanism of Atrial Fibrillation in Persistent Atrial Fibrillation Under Ultra-High-Resolution Mapping","ILVRA-PAFM-UAH","Inclusion Criteria:\n\n1. Patients aged 18 to 85 years;\n2. Diagnosed with drug-refractory, symptomatic, persistent atrial fibrillation; Definition: At least one electrocardiogram (ECG) record of an atrial fibrillation episode within 12 months prior to enrollment.\n3. Non-valvular atrial fibrillation;\n4. Able to understand the purpose of the study, voluntarily participate in the study, the patient or their legal representative signs the informed consent form, and willing to complete follow-ups as required by the study protocol.-\n\nExclusion Criteria:\n\n1. Atrial fibrillation secondary to thyroid disease or other reversible factors;\n2. Imaging studies indicating intracardiac thrombus;\n3. Moderate to severe mitral stenosis or regurgitation;\n4. Left ventricular ejection fraction \\\u003C40%, or New York Heart Association (NYHA) functional class III or IV;\n5. Unstable angina;\n6. Myocardial infarction (MI) or coronary artery bypass grafting (CABG) within 3 months prior to enrollment;\n7. Presence of mural thrombus, space-occupying disease, or other abnormalities that hinder vascular puncture or catheter manipulation;\n8. Contraindications to anticoagulation and a history of blood coagulation or bleeding abnormalities;\n9. Patients with active systemic infections; Patients who have had an atrial septal closure device implanted within the last 6 weeks;\n10. Female patients who are pregnant, breastfeeding, or unable to use contraception during the study period;\n11. Patients with a life expectancy of less than 12 months (e.g., advanced malignant tumors); patients who have had an atrial septal closure device implanted within the last 6 weeks;\n12. Conditions affecting vascular access;\n13. Patients who are concurrently participating in other drug or device clinical trials;\n14. Any other abnormalities or diseases that the investigator deems should exclude the patient from the study enrollment.",{"count":111,"type":22},[25],"The latest OCTARAY multi-electrode mapping catheter and TUREref technology were used to perform ultra-high precision mapping on the left atrial and left atrial auricle of persistent atrial fibrillation in the condition of sinus rhythm and atrial fibrillation respectively, and the density and accuracy of potential were significantly improved. According to the mapping results, the numerical calculation of the personalized low voltage region was carried out, and the personalized ablation route was designed according to the low voltage region.",[167],"Atrial Fibrillation Recurrent",[169],"心房颤动（Atrial Fibrillation）","2024-11-15",{"date":117,"type":42},{"date":170,"type":22},{"date":174,"type":22},"2026-04-05",{"name":48,"class":49},{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":184,"briefSummary":186,"conditions":187,"keywords":189,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":198,"locationsCount":50},"100559331","phase-4-clinical-study-on-efficacy-and-safety-of-hetrombopag-in-the-preoperative-patients-of-thrombocytopenia-100559331","NCT06562738","Clinical Study on Efficacy and Safety of Hetrombopag in the Preoperative Patients of Thrombocytopenia","Inclusion Criteria:\n\n1. Age ≥18 years old; diagnosis of immune thrombocytopenia.\n2. Platelets ≤75×10\\^9\u002FL before scheduled elective surgery.\n\nExclusion Criteria:\n\n1. History of allergy to Thrombopoietin Receptor Agonists (TPO-RA) drugs;\n2. Severe bleeding symptoms, such as gastrointestinal bleeding, bleeding of important organs, and intracranial bleeding;\n3. Thrombotic diseases, such as pulmonary embolism, arterial thrombosis and disseminated intravascular coagulation (DIC);\n4. Positive anti-human immunodeficiency virus antibody or anti-treponema pallidum specific antibody;\n5. New York Heart Association (NYHA) Grade 3 or 4 congestive heart failure;\n6. History of angina pectoris, myocardial infarction or cerebral infarction within 6 months before the screening period;\n7. Have an active infection that is difficult to control;\n8. Pregnant or lactating women;\n9. Other conditions determined by the investigator to be unsuitable for inclusion in the study",{"count":183,"type":22},55,[185],"PHASE4","This is an investigator-initiated, single-arm, prospective clinical study to evaluate the efficacy and safety of heptapopal in the treatment of thrombocytopenia prior to elective surgery",[188],"Thrombocytopenia",[190,188,191],"Hetrombopag","Preoperative","2024-08-17",{"date":194,"type":42},"2024-08-20",{"date":196,"type":42},"2024-06-01",{"date":100,"type":22},{"name":48,"class":49},""]