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Abbott Structural Heart Device Registry

NCT06590467 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2026-04-13

No results posted yet for this 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.

Conditions

  • Heart Diseases
  • ASD - Atrial Septal Defect
  • VSD - Muscular Ventricular Septal Defect
  • PFO - Patent Foramen Ovale
  • PIVSD - Post Infarct Muscular Ventricular Septal Defect
  • Valvular Heart Disease

Interventions

DEVICE

Amplatzer™ Occlusion Devices

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

DEVICE

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.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Ryan Palmer · Abbott

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-21
Primary Completion
2029-07-31
Completion
2039-11-30
FDA Device
Yes

Countries

  • United States
  • Denmark
  • Estonia
  • France
  • Germany
  • Ireland
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06590467 on ClinicalTrials.gov