Saint Laurent Du Var

Researchers are evaluating the Coroflex4 ISAR NEO coronary stent system, a sirolimus-eluting stent, in patients with coronary artery disease and ischemic heart disease. This international, multicenter, prospective, non-randomized post-market clinical follow-up study aims to confirm and support the device's clinical safety and performance in a real-world, unselected patient population, following daily clinical practice. The study complies with the European Union Medical Device Regulation requirements for post-market clinical follow-up. The study involves patients who have been treated or planned to be treated with the Coroflex4 ISAR NEO coronary stent system as intended by the manufacturer. The device is used in patients undergoing percutaneous coronary intervention (PCI) following the latest European Society of Cardiology recommendations. Eligible patients have novel lesion lengths of 2-4 mm. The study collects data from consecutive patients treated with the stent to evaluate outcomes in routine clinical settings without randomization. Participants will be monitored for safety and efficacy outcomes, including freedom from target lesion failure within 7 days after treatment. The research team will follow patients' clinical status and device performance as part of standard care. Informed consent is required, and patients will be observed to confirm the stent's safety and effectiveness under everyday medical practice conditions. The study does not specify a maximum age limit and includes adult patients aged 18 and older.

Paraprosthetic cardiac valve leaks are a complication that can occur after surgical or percutaneous heart valve replacement, potentially causing heart failure or serious breakdown of red blood cells. Researchers are studying the outcomes of a less invasive treatment option called percutaneous closure for these leaks, which has been developed for patients who face high risks with surgery. This research aims to assess both the technical success and clinical results of this procedure, as well as its impact on patients' quality of life, which is not yet well understood. The treatment involves placing an occluder or vascular plug device into the leak through a minimally invasive approach, usually accessing the heart via blood vessels in the leg or through the chest wall. Different types of devices may be used, chosen by the treating physician, and their effectiveness is checked using ultrasound imaging before final placement. This procedure is being evaluated in a European registry that collects data on its success, complications, and patient outcomes. Participants will be monitored over time to assess clinical success, which includes survival, hospitalizations for heart failure, need for blood transfusions, and further valve interventions. Quality of life will be measured before treatment and at several points afterward using a standard questionnaire. Additional evaluations include heart function tests and blood markers related to hemolysis and heart failure. The overall follow-up spans up to two years to capture both short- and long-term results of the procedure.

Researchers are observing the real-world use of the Maestro Platform to assist in laparoscopic surgery. The study focuses on how this device is used during surgery and monitors any related complications or issues. It aims to collect information on the safety and performance of the Maestro Platform during these surgical procedures. Patients scheduled for laparoscopic surgery will undergo the operation according to standard care practices, including typical port and instrument placements following local guidelines. The Maestro Platform may be used to hold and position the surgical scope and retractor as directed by the surgeon. Surgeons can switch back to manual minimally invasive surgery or convert to open surgery at any time if needed. Participants will be monitored for adverse events, including those related to the device or procedure, during and up to 30 days after surgery. The study tracks the completion of procedures using the Maestro Platform without needing to switch to other surgical methods due to device problems. Overall, the study records surgical outcomes and device safety over this period to better understand its use in actual clinical settings.

Researchers are collecting patient data from multiple centers in France on cardioneuroablation, a new procedure to treat vasovagal syncope, a condition causing fainting due to abnormal heart rate slowing. The study aims to evaluate how successful this treatment is, compare different techniques, and help hospitals establish their own cardioneuroablation programs. Important questions include which patients benefit most, which heart fat pads should be targeted, and the long-term effects of this approach. The treatment involves using radiofrequency energy to destroy specific nerve clusters called ganglionated plexi located in the fat pads around the heart's atria. This procedure targets patients with recurrent vasovagal syncope who experience significant pauses in their heartbeat. The study will observe patients undergoing scheduled cardioneuroablation to gather information from various centers. There is no mention of a control group or alternative treatments in this registry. Participants will be adults aged 18 to 100 with at least two episodes of vasovagal syncope in the past year and documented long pauses in heart rhythm during these episodes. Data collected includes treatment outcomes, recurrence of syncope over 12 months, and safety information such as contraindications to anticoagulation or cardiac CT scans. The study also tracks patient consent and affiliation with the national health system. Researchers aim to understand the procedure's effectiveness and safety through this registry over the course of one year.

This research aims to evaluate the safety and effectiveness of the Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System in treating patients with coronary artery disease who have atherosclerotic lesions between 36 mm and 44 mm in length in native coronary arteries with a vessel diameter of 2.25 mm to 4.0 mm. The study includes patients from the United States and other countries, with different follow-up durations based on location. Patients in the United States are followed for 2 years after the initial procedure, while those outside the United States are followed for 5 years. Participants will receive the Orsiro Mission stent, which is a device combining a cobalt chromium stent platform with a sirolimus drug contained in a bioabsorbable polymer coating. This stent is designed to be placed in the coronary artery to treat the lesion with a single device. The treatment targets one lesion per patient, with certain allowances for additional non-target lesion treatments using other approved methods if needed. Throughout the study, participants will have scheduled follow-up visits to monitor their health and the performance of the stent. In the United States, visits occur at 1, 6, 12, and 24 months after the procedure, while outside the United States, additional visits at 3 and 5 years are included. Researchers will assess the rate of target lesion failure at 12 months and monitor safety and device effectiveness through clinical evaluations and imaging as appropriate.