Bourdeaux

This registry study focuses on patients with mitral valve issues, including mitral regurgitation, mitral valve disease, and mitral annular calcification. It aims to observe clinical outcomes for those undergoing transcatheter mitral valve replacement (TMVR) in everyday medical practice across multiple countries. The study collects real-world data primarily from patients treated with TMVR, while patients who were evaluated but did not undergo TMVR are generally not included unless historical data show they received other treatments such as edge-to-edge repair, surgery, or medical therapy. The registry gathers information from patients who have undergone TMVR and monitors their status over time. Data includes echocardiography results before and after TMVR and other treatments. Patients must have been screened for TMVR and have at least 30 days of follow-up. The study does not assign specific treatments but records outcomes from standard clinical care involving TMVR. Participants provide information at baseline and during follow-up visits, including heart valve function evaluations and any complications related to the device used in TMVR. The main outcomes measured are the grade of mitral valve leakage at 12 months and the absence of device-related complications within 30 days. This data helps researchers understand safety and effectiveness aspects of TMVR over time in routine practice.

Researchers are evaluating the effectiveness of 177Lu-edotreotide compared to everolimus in patients with well to moderately differentiated neuroendocrine tumors of the lung and thymus that show high somatostatin receptor expression. This phase III, randomized international trial includes patients who need systemic therapy and aims to see if 177Lu-edotreotide can significantly improve progression-free survival compared to everolimus in these tumors. The study randomly assigns 170 patients in a 3:2 ratio to receive either 6 cycles of 7.5 ± 0.7 GBq of 177Lu-edotreotide or 10 mg of everolimus taken orally once daily. Patients with typical or atypical lung carcinoids or thymus neuroendocrine tumors, both functional and nonfunctional, are included. Tumor assessments using MRI or CT scans are done every 12 ± 2 weeks to monitor disease progression, and treatment is stopped if progression or significant toxicity occurs. Participants will undergo regular imaging and laboratory tests throughout the approximately 3-year study period to monitor tumor status and safety. Progression-free survival is the primary outcome measured during this time. Patients will continue scheduled assessments unless they withdraw consent. The study also collects tumor tissue samples for analysis and monitors patient-reported outcomes and safety throughout treatment and follow-up.

Researchers are evaluating an artificial intelligence (AI) system designed to improve predictions for transcatheter heart valve interventions, such as aortic, mitral, and tricuspid valve procedures. This non-interventional, retrospective study analyzes data from specialized centers worldwide to validate AI methods that could optimize patient outcomes by reducing human error and variability in cardiac imaging interpretation. The study uses AI algorithms based on deep learning, especially convolutional neural networks, to automatically analyze cardiac imaging data from multi-slice CT scans and transesophageal echocardiography (TEE). These AI tools segment important anatomical structures and measure them accurately, combining this information with clinical data to predict procedural success. The study includes patients who have undergone interventions like TAVI, TMVI, TTVI, M-TEER, and T-TEER, using specific imaging quality criteria for inclusion. Participants' pre-procedural imaging and clinical data are reviewed retrospectively to compare AI-generated predictions with manual assessments and actual patient outcomes 30 days after intervention. The main outcome measured is the accuracy of AI predictions compared to human evaluations and real clinical results. This approach aims to enhance patient selection and improve planning for transcatheter heart valve procedures.

Researchers are evaluating the efficiency of the PRPP (Perceive, Recall, Plan and Perform) task analysis system in supporting decision-making for people with aging psychiatric disorders living independently. The study focuses on individuals experiencing cognitive decline that affects daily living activities, aiming to facilitate choices that either maintain their independent housing or guide them toward suitable alternative living arrangements. This research is conducted within a specialized psychiatry unit focused on preventing long-term hospitalization for patients with chronic psychiatric conditions who have become dependent on care. The study involves passing the PRPP evaluation for two activities as a behavioral intervention. This approach integrates occupational therapy assessments to measure the impact of cognitive impairments on how participants process information and use cognitive strategies in daily tasks. The PRPP system supports personalized care plans by helping multi-professional teams decide the best ambulatory support for each participant. Participants will be assessed and monitored by a mobile multi-professional team and receive outpatient psychosocial rehabilitation at a day hospital. The main outcome measured is the efficiency of the PRPP system in supporting living orientation decisions nine months after inclusion. The study includes detailed assessments of occupational performance and cognitive function, aiming to support aging people with psychiatric disorders in maintaining autonomy and avoiding hospitalization.

Calciphylaxis is a rare and painful condition causing ischemic skin lesions due to blocked small blood vessels, mainly affecting patients with end-stage renal disease on hemodialysis. Researchers are conducting a prospective randomized controlled trial to evaluate the safety and effectiveness of adding rheopheresis treatment to standard care for these patients. Rheopheresis is a procedure using double-filtration plasmapheresis to remove specific high molecular weight proteins involved in inflammation and blood clotting. Participants will be randomly assigned to receive either rheopheresis or a sham-apheresis as an additional treatment alongside standard care. Rheopheresis is performed using an automated device (Plasauto) that filters plasma in a double-filtration process, while sham-apheresis uses the same device but returns untreated plasma to the patient. A total of 17 treatment sessions are planned over 12 weeks. During the study, participants will be monitored for complete healing of their calciphylaxis-related skin lesions after 12 weeks of treatment. The trial includes assessments of wound healing progress and safety measures. Participants must be adults on hemodialysis with calciphylaxis lesions, and the study aims to determine if rheopheresis improves healing compared to standard care alone.

Researchers are evaluating the safety and effectiveness of the Occlutech Atrial Flow Regulator (AFR) device in patients with Heart Failure. This international, multicenter follow-up study aims to identify any unknown side effects and better understand when this device should or should not be used. The study focuses on patients with chronic symptomatic heart failure and monitors their health for up to 36 months after the device implantation. Participants will receive the Occlutech AFR device, which is an interatrial shunt implanted through a minimally invasive transcatheter procedure. The treatment is done according to the device's instructions and routine clinical practice by experienced physicians. The study includes regular follow-up visits and evaluations that last for three years after implantation to assess the device's performance and safety. During the study, participants will have their vital signs checked and undergo laboratory tests, ECGs, echocardiograms, and complete quality of life questionnaires. Researchers will track major adverse cardiovascular and neurological events for one year after implantation as a primary outcome. The study monitors patients closely throughout the follow-up period to evaluate how well the device works and to detect any side effects or complications.