Evora

This research aims to understand how the Medtronic Evolut FX transcatheter aortic valve implantation TAVI System performs in adults with severe, symptomatic aortic stenosis who require valve replacement. The study focuses on whether using a standardized procedure for implanting this valve system can improve safety and efficiency. It also looks at patient outcomes both shortly after the procedure 30 days and in the longer term 1 year, including the need for pacemakers, complications, and valve function. Participants will receive the Medtronic Evolut FX TAVI System as part of their regular medical care for severe aortic stenosis. This is an observational registry capturing routine practice data, with no experimental treatments assigned. The study will follow patients from their hospital stay through 30 days and up to 1 year after the procedure to monitor health and recovery. During the study, participants will be closely observed through hospital records and follow-up visits to assess heart health, valve function, and recovery progress. Researchers will measure technical success immediately after the procedure, as well as monitor events like pacemaker implantation, hospital stay length, mortality, stroke, bleeding, kidney injury, vascular complications, valve issues requiring further treatment, rehospitalizations, and prosthetic valve function over 30 days and 1 year. A total of 500 participants across 12 hospitals will take part in this registry lasting until April 2028.

Researchers are evaluating 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. This prospective, single-arm, multicenter trial includes up to 267 patients and follows them for up to five years after valve implantation. The study aims to gather important data beyond an initial feasibility study to better understand this devices performance over time. Participants will receive the Vienna Aortic Valve SE System through a transcatheter aortic valve implantation TAVI procedure. After implantation, patients will have 11 scheduled visits, including follow-ups at 30 days, 3 months, 6 months, 1 year, and annually up to 5 years. These visits allow researchers to monitor the devices safety and effectiveness throughout the study period. During the trial, participants will undergo clinical evaluations including assessments of mortality, valve function, and heart-related events. Quality of life and exercise capacity will also be measured. Monitoring includes checking for complications like bleeding or conduction problems requiring pacemakers. The study concludes after each participant completes their 5-year follow-up visit, providing long-term information on the valve systems outcomes.

Researchers are evaluating the safety and performance of the Myval THV series device used in Transcatheter Aortic Valve Implantation TAVI procedures for patients with symptomatic severe native aortic valve stenosis. This prospective, single-arm, multi-centre registry aims to gather real-world data on this treatment approach to better understand its use in this condition. Participants will undergo the TAVI procedure using the Myval THV series device. The study is observational and does not involve comparison groups or placebo treatments. The registry will collect data on the procedure and device performance over time, focusing on safety outcomes within 30 days and extending observations up to 12 months. During the study, participants will be monitored through registry procedures and follow-up visits. Researchers will assess safety outcomes at 30 days and measure both safety and performance at 30 days and 12 months after the procedure. Participants will provide informed consent and are expected to comply with all registry requirements, including follow-up evaluations.

Spontaneous coronary artery dissection SCAD is a recognized cause of non-atherosclerotic acute coronary syndromes, mainly affecting young women without typical risk factors. Researchers are building the first pan-European SCAD registry to improve understanding of this conditions diagnosis and management, inform guidelines, educate clinicians, and promote research. This international, multicenter, observational study includes both retrospective and prospective patient data. The study collects data without any treatment interventions, enrolling at least 500 new patients and 500 historical cases from about 30 countries and 120 sites. Patient information is gathered from their first SCAD event, at enrollment, and then yearly for up to five years or until study completion. There are no study drugs or procedures involved as it is purely observational. Participants will provide data at multiple time points including baseline and yearly follow-ups for up to five years. Researchers will review patient status, vital signs, recurrent SCAD events, imaging results, medications, menstrual and obstetric history, and discharge details. Additional information on procedures, other coronary events, symptoms, pregnancy and hormonal therapy, exercise habits, mental health, and employment after SCAD will also be collected. This allows a comprehensive understanding of SCAD over time.