[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Mitera Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100652519","intracardiac-echocardiography-guided-versus-electroanatomical-mapping-guided-pulsed-field-ablation-for-paroxysmal-atrial-fibrillation-100652519",false,"NCT07772518","Intracardiac Echocardiography-guided Versus Electroanatomical Mapping-guided Pulsed Field Ablation for Paroxysmal Atrial Fibrillation","Intracardiac Echocardiography-guided Versus Electroanatomical Mapping-guided Pulsed Field Ablation for Paroxysmal Atrial Fibrillation - the PFA-VISION Randomized Trial (Pulsed Field Ablation - Visualization and Imaging Strategies for Isolation Outcomes in Paroxysmal Atrial fibrillatioN)","PFA-VISION","Inclusion Criteria:\n\n* History of paroxysmal AF.\n* Scheduled to undergo AF catheter ablation with the FARAPULSE (Boston Scientific) PFA system.\n\nExclusion Criteria:\n\n* Any contraindication to AF catheter ablation.\n* History of previous left atrial ablation.\n* Need for additional ablation beyond pulmonary vein isolation.\n* Inability to provide written informed consent.\n* Any factor that, in the investigator's judgment, renders the patient unsuitable for participation or may compromise their safety.\n* eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2\n* NYHA class III\u002FIV heart failure\n* Major cardiovascular events within 90 days\n* Secondary AF owing to reversible causes\n* Intracardiac thrombus or other conditions making left atrial instrumentation unsafe\n* Severe valvular disease","ALL","18 Years",{"count":20,"type":21},292,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a prospective, randomized clinical trial, which will be conducted in selected European centers. The objective is to compare two commonly used strategies to guide pulsed-field ablation (PFA) in patients with paroxysmal atrial fibrillation (AF). Patients with paroxysmal AF planned to undergo PFA will be randomized to intracardiac echocardiography (ICE)-guided or electroanatomical mapping-guided (OPAL HDx mapping system) ablation procedure. The primary efficacy endpoint will be freedom from atrial arrhythmia (AF, atrial flutter, atrial tachycardia) recurrence off antiarrhythmic drug therapy and without the need for electrical cardioversion or repeat ablation, with a follow-up duration of 12 months. The primary safety endpoint will be the incidence of predefined safety outcomes.",[27],"Paroxysmal Atrial Fibrillation (PAF)",[29,30,31,32,33,34],"atrial fibrillation","paroxysmal atrial fibrillation","intracardiac echocardiography","ICE","FARAVIEW","pulsed field ablation","RECRUITING","2026-08-13",{"date":38,"type":39},"2026-08-19","ACTUAL",{"date":41,"type":39},"2026-08-01",{"date":43,"type":21},"2028-12",{"name":45,"class":46},"Mitera Hospital","OTHER",8,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":69,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100570799","vocorder-device-validation-in-clinical-settings---continuous-monitoring-of-individuals-vocorder-clinical-validation-vcv-100570799","NCT06711939","Vocorder Device Validation in Clinical Settings - Continuous Monitoring of Individuals (Vocorder Clinical Validation-VCV)","Vocorder Device Validation in Clinical Settings - Continuous Monitoring of Individuals (Vocorder Clinical Validation-VCV). This Clinical Study Will Explore the Correlation Analysis Between Volatile Organic Compounds (VOC) Profiles in Breath As Detected by the VOCORDER Breath Analyser and Electronic Medical Data As Collected by Medical Professionals. the Obtained Results Are Expected to Be Significant in Refining the Technology of Breath Analysis in the VOCORDER Breath Analyser for the Early Detection of Diseases of Interest.","VCV","Inclusion Criteria:\n\n* Patients aged 18-75 years of both genders, selected according to the following inclusion criteria:\n\n  1. Patients\\>18 years of age of both genders\n  2. They must be able to communicate and understand the information given to them by the MITERA staff.\n  3. Suffer from the disease under investigation.\n  4. The disease must be at the earliest possible stage, i.e., the patients must not yet have started treatment.\n  5. Patients should have no other serious comorbidities that affect the derived measurements. Patients will be selected in collaboration with the clinicians responsible for the treatment and\u002For hospitalisation of patients with the diseases under investigation.\n\n     Criteria 1, 2, and 3 are mandatory for enrollment in the study. For the enrollment of the patients in the study specific documentation of the disease should be available to the project team as following:\n* Healthy controls of both sexes, aged between 20 and 75 years, who do not suffer from the diseases under investigation will be selected for participation in the study at the same time as the patients.\n\nExclusion Criteria:\n\n* Lack of signed consent\n* Lack of co-operation due to any reason\n* Failure to follow the recommendations on the requirements prior to the breath sampling procedure\n* Inability to provide a reliable breath sample\n* Any treatment, specific diet, surgery, or other intervention having been initiated between obtaining samples for breath VOCs.",true,"75 Years",{"count":59,"type":21},515,"OBSERVATIONAL","This is performed under Vocorder project that is Co-Funded by the European Union. (Grant Agreement 101115442 VOCORDER HORIZON EIC-2022-PATHFINDERCHALLENGE-01). The projects has 9 work packages (one dedicated to the clinical study) and 12 partners (collaborators). MITERA Hospital serves as the project Coordinator as well as the leader of the clinical study.\n\nVOCORDER aims to create a paradigm shift in healthcare monitoring by developing a portable device for continuous assessment of health through breath analysis.\n\nOur mission is to make health monitoring seamless and non-intrusive, empowering individuals and healthcare professionals with real-time data and proactive health management.\n\nOur vision is to make continuous health monitoring a part of everyday life, helping in early disease detection and management. We are on a mission to create accessible, easy-to-use technology that integrates seamlessly into daily routines.\n\nOur objective is to create a tool designed for the discreet and continuous monitoring of human health. This involves the development and implementation of a system that can consistently assess, process, and analyze human breath. The key aim is to detect early indicators of diseases, thereby facilitating timely and proactive healthcare interventions.\n\nStrategic objectives\n\n1. Provide a solution for easy-to-use breath analysis able to monitor the health of any individual at any setting.\n2. Develop and demonstrate the beyond state-of-the-art technologies needed to implement the VOCORDER breath analysis apparatus.\n3. Develop a health monitoring apparatus people can easily integrate into their everyday life.\n\nScientific and technological Objectives\n\n1. Demonstration of QCLs and ICLs monolithically integrated arrays.\n2. Integrate QCLs\u002FICLs arrays with MPLC components for beam combing and providing high quality beam profile.\n3. Implement a detector-less sensing scheme.\n4. Enable AI-based breath analysis for the identification of health conditions.\n5. Implement clinical studies of VOCORDER.",[63,64,65,66,67,68],"Cancer of the Breast","Cancer of Stomach","Colon Cancer","Lung Cancers","Kidney Insufficiency","Pneumonia",[70,71,72,73,74,75,76,77,78],"VOC","breath analysis","organ insufficiency","infections","Lung cancer","Gastric and colon cancer","Breast cancer","Kidney insufficiency","Infections - Pneumonia","NOT_YET_RECRUITING","2024-11-27",{"date":82,"type":39},"2024-12-02",{"date":84,"type":21},"2024-12-09",{"date":86,"type":21},"2026-12-31",{"name":45,"class":46},1,""]