Bad Rothenfelde

The Abbott SH Device Registry is designed to confirm the safety and performance of commercially available Abbott SH devices as they are used in routine hospital practice or SOC procedures. Patients will be screened for eligibility and willingness to participate prior to the procedure or, if enrolled retrospectively, within the following timeframes: * Amplatzer portion: within 7 days post-procedure * Cardiac Surgery portion: within 6 months post-procedure. All patients who provide informed consent and undergo an implant attempt with an applicable Abbott SH device are eligible to participate in the Registry. The Registry anticipates that approximately 500 subjects per year will be enrolled. The projected enrollment period is at least 5 years. The Registry will be conducted at approximately 25 sites worldwide. Additional sites may be approached for participation in the Registry as needed. Follow-up visits should align with the site's routine SOC visits for the associated procedure. Data collection will occur post-screening and consent and at post-procedure SOC follow-up visit(s). Where applicable, follow-up visits may occur over the telephone, virtually, or in-office, following SOC practice. The follow-up duration will depend on the Abbott device(s) used during the procedure. Certain devices will utilize data collection at discharge (or 7 days post procedure, whichever comes first), short-term (1 - 3 months as applicable), a mid-term (6 months), and long-term follow-up (12 months) visits to support clinical safety and performance data requirements. Alternatively, some devices will have follow-up visits extending up to 10 years to monitor subjects throughout the devices' lifetime. A surgical valve-specific "Line Extension Sub-Study" is included in the protocol to collect data at European sites with the intention of applying for approval in the US for 2 specific surgical aortic valve sizes (Epic Max 27mm, and the Epic Plus Supra 29mm).

The study is a prospective, observational, single-arm, multi-center registry. The patients must undergoing bioprosthetic aortic valve replacement with the Avalus valve. This prospective registry aims to examine the outcome and performance of surgical aortic valve replacement with the Avalus pericardial bioprosthesis. The goal of this project is to evaluate the real world results of aortic valve replacement with the Avalus valve. This will result in clinical and hemodynamic knowledge of this particular valve. The investigators are aiming for 1000 patient inclusions distributed over 40 sites across Europe and potentially also involving Canada. Intentionally, we kept the inclusion criteria as wide as possible in order to obtain a real-world experience with and performance of the bioprosthesis. Patients younger than 18 years and salvage procedures are the only exclusion criteria from the registry. Outcome is evaluated in accordance with the VARC-2 criteria up to 1-year postoperatively.

This registry is being conducted to support ongoing post-market surveillance activities.

The primary aim of this study is to evaluate the long-term effectiveness and safety of MV TEER compared with surgical repair in patients with primary, degenerative MR. The secondary aim is to analyze the relationship between the adequacy of MR correction at one-year post intervention and longer-term clinical outcomes (death, heart failure hospitalizations/urgent care visits, valve re-interventions, and quality of life). The tertiary aim of this trial is to evaluate a range of patient-centered outcomes (quality of life, functional status, and discharge location) of transcatheter edge-to-edge MV repair compared with MV surgical repair in patients with primary, degenerative mitral regurgitation. This study is closely integrated with the PRIMARY Ancillary Substudy (NCT07103733) The patient population for this trial consists of adult patients with severe, primary degenerative MR for whom the local heart team has verified that an indication for MV intervention is present and for whom both transcatheter edge-to-edge and surgical repair strategies are anatomically feasible. Because the use of the commercial edge-to-edge mitral repair device in the U.S. is approved only in patients considered to be at prohibitive risk of MV surgery by a heart team, use of such devices in this trial is considered investigational by the FDA. As such, this trial will be conducted under an Investigational Device Exemption (IDE). Outcomes will be measured from randomization over a period of 5 years post intervention. The estimated enrollment period is 36 months, and all patients will be followed from randomization for up to 10 years post intervention for particular endpoints. Long-term follow-up will include leveraging administrative datasets linked to clinical trial data.

Observational, multicentre, international retrospective and prospective cohort study. Since this is an observational study, a formal sample size is not necessary. At least 500 prospectively recruited patients and 500 historical cases will be enrolled. Patient data will be collected at the following time-points: * First SCAD event visit (retrospectively on chart review) * First follow-up: at time of enrolment * Yearly follow-up: up to 1, 2, 3, 4 and 5 years post enrolment or until study completion Approximately 30 countries and 120 sites will participate in this registry.