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SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy

NCT03924661 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-04-13

No results posted yet for this study

Summary

This PAS is an observational, non-randomized, multi-center, single arm, clinical study to evaluate long term safety and effectiveness of the SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve (15 AHPJ-505) as a replacement device for pediatric patients with a diseased, damaged, or malfunctioning aortic valve.

Conditions

  • Aortic Valve Disease

Interventions

DEVICE

Aortic Valve Replacement

SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve as a replacement device for patients with a diseased, damaged, or malfunctioning aortic valve

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Ryan Palmer · Abbott Medical Devices

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-24
Primary Completion
2026-06-30
Completion
2028-10-31
FDA Device
Yes

Countries

  • United States
  • Germany

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 NCT03924661 on ClinicalTrials.gov