Abbott Structural Heart Device Registry

Condition(s) studied

Investigational drug(s) / intervention(s)

Amplatzer™ Occlusion Devices: The Amplatzer™ Occluders are devices intended for the occlusion of multiple septal heart defects.

Epic™ Surgical Tissue Heart Valve devices: The Epic™ valves are indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic/mitral heart valve. It may also be used as a replacement for a previously implanted aortic/mitral prosthetic heart valve.

Study summary

The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting. The Registry primarily involves gathering data from routine hospital practices and standard-of-care (SOC) procedures administered to patients. All devices used in these procedures must be commercially available to the participating site. A list of specific devices covered by the Registry are available upon request from the Sponsor. Data generated by the Registry will be used to meet regulatory requirements, such as the European Union Medical Device Regulations 2017/745, that require active post-market clinical follow-up (PMCF) for all commercially available devices.

Eligibility

Primary outcome measure(s)

• Primary Safety Endpoint — 7 days
  The primary safety endpoint will be the proportion of subjects with device- and/or procedure-related serious adverse events (SAEs) occurring within 7 days of the procedure.
• Primary Effectiveness Endpoint — Baseline
  The primary effectiveness endpoint will be the proportion of procedures that achieved technical success, defined as completion of the procedure with an applicable Abbott SH device implanted

Trial sites (36)