Bad Rothenfelde

Researchers are evaluating the safety and performance of Abbott's Structural Heart (SH) devices used in routine hospital practices and standard-of-care procedures for patients with various heart diseases including septal defects and valvular heart disease. This Registry study collects real-world data to meet regulatory requirements such as the European Union Medical Device Regulations that mandate active post-market clinical follow-up for all commercially available devices. The study is designed to include patients who undergo procedures involving Abbott SH devices and to provide ongoing safety and performance data over time. The study includes devices like the Amplatzer Occlusion Devices, which are used to close multiple septal heart defects, and the Epic Surgical Tissue Heart Valve devices, which serve as replacements for diseased or damaged native or prosthetic aortic or mitral valves. Patients may be enrolled before or shortly after the implant procedure, with specific follow-up timeframes varying by device type. Follow-up visits align with routine care and may be conducted in person, by phone, or virtually. The follow-up period ranges from discharge or 7 days post-procedure to as long as 10 years, depending on the device, to ensure thorough monitoring of device safety and effectiveness. Participants will provide informed consent and be monitored through their standard care visits, with data collected at multiple points including discharge, short-term (1-3 months), mid-term (6 months), and long-term (12 months or up to 10 years) follow-ups. A special sub-study focuses on specific surgical valve sizes at European sites for regulatory approval purposes. The study aims to enroll about 500 subjects per year over at least five years at approximately 25 sites worldwide, with assessments including clinical outcomes and device-related safety measures.

Researchers are conducting a prospective, observational, single-arm, multi-center registry to evaluate the outcomes and performance of surgical aortic valve replacement using the Avalus pericardial bioprosthesis. This study focuses on patients undergoing bioprosthetic aortic valve replacement with the Avalus valve, aiming to gather real-world clinical and hemodynamic data. The registry plans to include approximately 1000 patients from around 40 sites across Europe and possibly Canada, with broad inclusion criteria to reflect real-world use. Participants will receive the Avalus bioprosthetic valve during their surgical aortic valve replacement procedure. The study does not involve additional interventions beyond the standard surgical treatment, as it is an observational registry. The inclusion criteria are intentionally broad, excluding only patients under 18 years of age and those requiring salvage surgery. Data collection and evaluation will follow the Valve Academic Research Consortium-2 (VARC-2) criteria, with patient outcomes assessed up to one year after surgery. During the study, researchers will monitor participants for the composite outcome of all-cause mortality and disabling stroke within one year postoperatively. Patients will be informed of the risks and requirements of the registry and must provide informed consent. The study focuses on collecting detailed clinical and hemodynamic information to understand the safety and efficacy of the Avalus valve in a real-world patient population over the course of 12 months.

Researchers are conducting a registry study to support ongoing post-market surveillance of surgical heart valve devices used in treating valve disease of the heart. The study aims to monitor and identify unique failure modes and trends in adverse effects related to these devices over a period of 10 years. This long-term follow-up helps ensure continued safety and performance of the products after they have been approved for use. Participants in this registry receive surgical heart valve repair or replacement products made by Medtronic. The study includes patients who have already been treated or are intended to receive these eligible devices. Enrollment can occur during a specific window after treatment or retrospectively. The study focuses on collecting data related to the device performance and patient outcomes in real-world clinical use. During the study, participants will be followed for up to 10 years to track any device-related issues or adverse effects. Researchers will collect information through regular follow-up assessments, monitoring the safety and effectiveness of the heart valve devices. The registry allows for long-term data collection to better understand the durability and risks associated with these surgical heart valve products.

Researchers are evaluating two different treatments for adults aged 60 years and older with severe primary degenerative mitral regurgitation (MR), a condition affecting the heart's mitral valve. This multicenter, open-label, randomized trial compares mitral valve transcatheter edge-to-edge repair (TEER) with traditional surgical repair. The study aims to assess the long-term effectiveness, safety, and patient-centered outcomes such as quality of life and functional status. It will take place in multiple countries including the U.S., Canada, Germany, Spain, and the United Kingdom, and includes devices legally approved in each country. The trial is conducted under an Investigational Device Exemption (IDE) due to regulatory considerations in the U.S.

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.