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ACTIVE NOT RECRUITING
NCT03924661

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

Sponsor: Abbott Medical Devices

View on ClinicalTrials.gov

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.

Official title: A Single Arm, Non-randomized, Multi-center Clinical Study of the SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2019-10-24

Completion Date

2028-10

Last Updated

2025-02-11

Healthy Volunteers

No

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

Locations (13)

Children's Hospital Los Angeles (USC)

Los Angeles, California, United States

Valley Children's Hospital

Madera, California, United States

Sutter Medical Center, Sacramento

Sacramento, California, United States

Variety Children's Hospital

Miami, Florida, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Dell Children's Medical Center

Austin, Texas, United States

Children's Medical Center Dallas

Dallas, Texas, United States

Sana - Herzchirurgische Klinik Stuttgart GmbH

Stuttgart, Baden-Wurttemberg, Germany

Deutsches Herzzentrum München des Freistaates Bayern

München, Bavaria, Germany

Herzzentrum Leipzig GmbH

Leipzig, Saxony, Germany

Medizinische Hochschule Hannover

Hanover, Germany