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Clinical Trials in Germany / NCT03924661
Active, not recruiting Observational

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

NCT03924661 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2019-10-24
Last updated
2026-04-13

Condition(s) studied

Aortic Valve Disease

Investigational drug(s) / intervention(s)

Aortic Valve Replacement

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

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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Inclusion criteria for prospectively enrolled subjects * Subject's legal guardian must provide written informed consent prior to any clinical study related procedure. * Subject requires aortic valve replacement and is intended to be implanted with a 15mm SJM15 AHPJ-505 MHV as determined by the implanting physician in accordance with the Instructions for Use. * The legal guardian and site agree to follow the subject per the assessment schedule and complete all required assessments per this protocol for the duration of the clinical study. * Inclusion criteria for retrospectively enrolled subjects : In an effort to ensure data on all real-world use conditions are consistently collected and reported on, a subject is eligible to participate in this post-approval study if he/she meets all of the following inclusion criteria and meets no exclusion criterion. For those subjects with a previous implant attempt to be eligible for study participation, the following inclusion criteria must be met: * Echocardiography data at a time point greater than 90 days is available or may be acquired. * An implant was attempted with the 15mm MHV, where implant attempt is defined as the device physically contacting the subject's cardiac anatomy. * Either: * For living subjects who already received the 15mm MHV, the legal guardian signs the study informed consent for this protocol allowing access to all relevant historical medical information, and complete all required assessments according to this protocol from the time of consent going forward (if applicable). OR * For subjects who are deceased or explanted, an implantation with 15mm MHV was attempted and the subject's legal guardian provides written informed consent for retrospective data collection of patient and study valve related information through death or explant of the study device. Exclusion Criteria: * Exclusion criteria for prospectively enrolled subjects: Subject has a contraindication to anticoagulant/antiplatelet medication. * Exclusion criteria of retrospectively enrolled subjects: None

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
Children's Hospital Los Angeles (USC) Los Angeles California
Valley Children's Hospital Madera California
Sutter Medical Center, Sacramento Sacramento California
Variety Children's Hospital Miami Florida
Children's Healthcare of Atlanta Atlanta Georgia
University of Mississippi Medical Center Jackson Mississippi
Cincinnati Children's Hospital Cincinnati Ohio
Dell Children's Medical Center Austin Texas
Children's Medical Center Dallas Dallas Texas
Sana - Herzchirurgische Klinik Stuttgart GmbH Stuttgart Baden-Wurttemberg
Deutsches Herzzentrum München des Freistaates Bayern München Bavaria
Herzzentrum Leipzig GmbH Leipzig Saxony
Medizinische Hochschule Hannover Hanover Germany

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03924661 on ClinicalTrials.gov ↗ ← All trials in Germany