[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":20,"conditions":21,"keywords":23,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100638939","post-market-clinical-follow-up-study-on-the-performance-and-safety-of-coronary-artery-perfusion-cannula-used-during-cardiopulmonary-bypass-100638939",false,"NCT07620847","Post-market Clinical Follow-up Study on the Performance and Safety of Coronary Artery Perfusion Cannula Used During Cardiopulmonary Bypass","Inclusion Criteria:\n\n* Patients who have consulted the Department of Cardiovascular Surgery and for whom the physician has decided to perform heart surgery using the cardiopulmonary bypass technique,\n\n  * Patients for whom the use of a coronary artery perfusion cannula is planned during surgery\n  * Patients who, prior to surgery, have provided consent in the \"Cardiovascular Surgery Department Information and Consent Form, Use of Patient Data for Educational and Research Purposes\" section regarding the use of their data\n\nExclusion Criteria:\n\n* Patients with ostial calcification and\u002For an ostium that is too small for the cannula tip to fit through,\n\n  * Patients known to have hypersensitivity to any of the materials used in the device components\n  * Patients who have difficulty understanding the study and complying with it\n  * Patients who may pose a conflict of interest (e.g., relatives of employees of the sponsoring company)\n  * Patients who have participated in any clinical trial within the past 30 days","ALL",{"count":17,"type":18},20,"ESTIMATED","OBSERVATIONAL","Prior to the implementation of the Medical Device Regulation (MDR), clinical evaluation of older devices was carried out by Notified Bodies (MBs) based on clinical data obtained from equivalent devices, and CE certification was granted to devices exhibiting similar characteristics. Following the transition to the MDR, the European Union Commission's MEDDEV 2.12\u002F2 guidance emphasizes that MBs, which issued CE certificates according to previous practices, should organize Post Marketing Clinical Follow-up (PMCF) studies to verify the performance and safety of the device throughout its lifecycle in accordance with its intended use for which it bears the CE mark. Thus, PMCF studies are planned to demonstrate that medical devices that were previously CE marked according to previous practices are used safely for patients throughout their lifecycles.",[22],"Cardiopulmonary Bypass",[24,25,26,27,28,29],"Coronary artery perfusion","coronary ostium","cardioplegia","cardioplegia cannula","antegrade cannula","antegrade cardioplegia","NOT_YET_RECRUITING","2026-06-01",{"date":33,"type":34},"2026-06-02","ACTUAL",{"date":36,"type":18},"2026-07-01",{"date":38,"type":18},"2026-10-01",{"name":40,"class":41},"Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":66,"locationsCount":4},"100637822","post-market-clinical-follow-up-study-on-the-performance-and-safety-of-a-vent-catheter-used-during-cardiopulmonary-bypass-100637822","NCT07628920","Post-market Clinical Follow-up Study on the Performance and Safety of a Vent Catheter Used During Cardiopulmonary Bypass.","Inclusion Criteria:\n\n* Patients who have consulted the Department of Cardiovascular Surgery and for whom the physician has decided to perform heart surgery using the cardiopulmonary bypass technique,\n\n  * Patients for whom the use of a vent catheter is planned during surgery\n  * Patients who, in the \"Use of Patient Data for Educational and Research Purposes\" section of the Department of Cardiovascular Surgery Informed Consent Form, have given permission for their data to be used\n\nExclusion Criteria:\n\n* • Patients with diseased or abnormal tissue in the catheter placement site\n\n  * Patients with intracardiac and\u002For major intravascular thrombi and\u002For masses\n  * Patients with left atrial\u002Fventricular myxoma\n  * Patients who have difficulty understanding or complying with the study\n  * Patients who may pose a conflict of interest (e.g., relatives of employees of the sponsoring company)\n  * Patients who have participated in any clinical trial within the past 30 days",{"count":49,"type":18},45,"Prior to the implementation of the Medical Device Regulation (MDR), the clinical evaluation of existing devices was conducted by Notified Bodies (NBs) based on clinical data obtained from equivalent devices, and CE certificates were issued for devices exhibiting similar characteristics. Following the transition to the MDR, the European Commission's Guidance Document MEDDEV 2.12\u002F2 highlighted that Notified Bodies, which issued CE certificates under the previous regime, must now organize Post-Marketing Clinical Follow-up (PMCF) studies to verify the performance and safety of the device in accordance with its intended use throughout its lifecycle. Consequently, PMCF studies are being planned to demonstrate that medical devices previously marked with the CE mark under the old regulations are used safely for patients throughout their lifecycle.\n\nPrimary Objective To demonstrate the performance of the Bıçakcılar Vent Catheter in patients for whom its use is planned, in accordance with the device's intended purpose as outlined in the user manual, taking into account the following aspects: bleeding, trauma, passage manipulation, insertion and removal, compliance with the intended use, occlusion, retention of debris, effective use, and maintenance of its form",[52],"Cardiopulmonary Bypass Surgery",[54,55,56,57,58,59,60,61,27],"'vent catheter'","PMCF","Cardiopulmonary bypass surgery","ostial cannula","Left ventricule","PMCF Study","Ventricular vent","heart ventilation",{"date":63,"type":34},"2026-06-05",{"date":36,"type":18},{"date":38,"type":18},{"name":40,"class":41},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":74,"conditions":75,"keywords":76,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":85,"leadSponsor":86,"locationsCount":4},"100637345","post-market-clinical-follow-up-study-on-the-performance-and-safety-of-the-aortic-root-cannula-used-in-cardiopulmonary-bypass-surgery-100637345","NCT07628907","Post-Market Clinical Follow-up Study on the Performance and Safety of the Aortic Root Cannula Used in Cardiopulmonary Bypass Surgery","Inclusion Criteria:\n\n* Patients who have consulted the Department of Cardiovascular Surgery and for whom the physician has decided to perform heart surgery using the cardiopulmonary bypass technique,\n\n  * Patients for whom the use of an aortic root cannula is planned during surgery\n  * Patients who, prior to surgery, have provided consent in the \"Cardiovascular Surgery Department Information and Consent Form, Use of Patient Data for Educational and Research Purposes\" section regarding the use of their data\n\nExclusion Criteria:\n\n* Patients known to have hypersensitivity to any of the materials used in the device components (PVC, ABS, stainless steel)\n\n  * Patients with calcified aorta, aortic valve insufficiency, occluded coronary arteries, the presence of adventitia or plaques, fibrosis in the aortic wall, or low arterial pressure Patients who have difficulty understanding the study and complying with it\n  * Patients who may pose a conflict of interest (e.g., relatives of employees of sponsoring companies)\n  * Patients who have participated in any clinical trial within the past 30 days",{"count":17,"type":18},"Prior to the implementation of the Medical Device Regulation (MDR), the clinical evaluation of existing devices was conducted by Notified Bodies (NBs) based on clinical data from equivalent devices, and CE marking was granted to devices demonstrating similar characteristics. Following the transition to the MDR, the European Commission's Guideline MEDDEV 2.12\u002F2 noted that, compared to previous practices, Notified Bodies issuing CE certificates must verify the performance and safety of the device throughout its lifecycle in accordance with its intended use by conducting Post Marketing Clinical Follow-up (PMCF) studies are required to verify the performance and safety of the device in accordance with its intended use throughout its lifecycle. Consequently, PMCF studies are being planned to demonstrate that medical devices previously granted CE marking under the old practices can be used safely by patients throughout their lifecycle.",[52],[77,78,79,80,81,29,82],"aortic root","cardiopleagia cannula","aortic root cannula","aortic ventilation","cardiopulmonary bypass","coronary artery",{"date":63,"type":34},{"date":36,"type":18},{"date":38,"type":18},{"name":40,"class":41},""]