Abbott Structural Heart Device Registry

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 (The ENDURE Study): 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).

Inclusion criteria

• Subject is expected to undergo an implant attempt using one or more Abbott Structural Heart devices covered in this Registry or has previously undergone an implant attempt within the timeframes specified in the device-specific appendices.
• Subject is willing and able to comply with the site's standard of care follow-up schedule.
• Subject is willing to provide appropriate informed consent for Registry participation. For deceased subjects enrolled retrospectively, local regulations and EC/IRB recommendations regarding consent and the protection of personal data must be followed.

Exclusion criteria

• Subject is participating in another clinical study that would affect the results of this Registry.