Evora

This research aims to understand how the Medtronic Evolut2 FX+ transcatheter aortic valve implantation (TAVI) System works in adults with severe, symptomatic aortic stenosis who need their aortic valve replaced. It focuses on whether using a standardized implantation procedure can improve safety and efficiency for patients. The study also looks at short-term outcomes within 30 days and long-term outcomes at 1 year, including the need for a pacemaker, possible complications, and how well the valve functions over time. Participants will receive the Medtronic Evolut2 FX+ TAVI System as part of their usual medical care. The procedure follows a standardized approach designed to optimize results. The study does not mention additional comparison groups or alternative treatments. All participants will undergo this valve replacement during their hospital stay. During the study, participants will be monitored while in the hospital, and then followed up at 30 days and again at 1 year. Researchers will check heart health, valve function, recovery progress, and any complications that arise. The main outcome measured immediately after the procedure is the technical success of the valve implantation based on VARC-3 criteria. A total of 500 patients will take part across 12 hospitals in Portugal.

The purpose of this trial is to determine the safety and effectiveness of the Vienna Aortic Valve SE System, a new self-expanding transcatheter heart valve, in patients with symptomatic severe aortic stenosis (SSAS). This is a prospective, single arm, multicenter study in an expanding cohort of symptomatic patients with severe aortic stenosis following the FIH feasibility study. The clinical investigation comprises 11 visits (V1 to V11). After implantation of the IMD at visit 2, safety and effectiveness assessment of the device will be performed at 30 days (V4), 3 months (V5), 6 months (V6), 1 year (V7) and every year thereafter up to 5 years post-implantation (V8 to V11). In summary, the clinical investigation for the individual patient will end after 5 years with a full clinical evaluation. The primary study endpoints for safety and effectiveness will be reached at 30-day follow-up timepoint. The clinical trial is completed after all 267 patients, that are not prematurely withdrawn, have completed their 5-year follow-up visit involving all specified assessments.

Researchers are evaluating the safety and performance of the Myval transcatheter heart valve (THV) series using the Transcatheter Aortic Valve Implantation (TAVI) procedure in patients with symptomatic severe native aortic valve stenosis. This is a prospective, single-arm, multi-center registry study focusing on adults over 18 years old who require this treatment for their severe aortic valve condition. Participants will receive the Myval THV series device through the TAVI procedure, which is a less invasive method to replace the aortic valve. The study does not include a comparison group and follows patients who undergo this procedure to gather safety and performance data. Throughout the study, participants will be monitored for safety outcomes, including assessments up to 30 days after the TAVI procedure. Researchers will collect data on the procedure's success, patient health, and any complications. Participants are expected to undergo all registry procedures and follow-up visits as required for thorough monitoring during the study period.

Spontaneous coronary artery dissection (SCAD) is a cause of acute coronary syndromes that mainly affects young women without typical risk factors for atherosclerosis. Recent advances in understanding SCAD have come from regional and national registries, but there is a need for international collaboration to better understand diagnosis, treatment, and outcomes. This study aims to create the first pan-European SCAD registry to improve knowledge, guide clinical practice, and support research. This is an observational, multicenter, international retrospective and prospective cohort study involving at least 500 patients recruited prospectively and 500 historical cases. Data will be collected from patients diagnosed with SCAD within the past 10 years, including information from the first SCAD event and yearly follow-ups up to 5 years after enrollment. Approximately 30 countries and 120 sites will participate, and no treatments or interventions will be given as part of the study. Participants will have their medical records and coronary angiographic images reviewed at baseline and will be followed annually for up to 5 years. Information collected will include patient status, vital signs, recurrent SCAD events, imaging results, medications, menstrual and obstetric history, and discharge details. The study aims to gather comprehensive data to better understand SCAD management and long-term outcomes.