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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-24

Study Completion Date

2028-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

HeartMate 3 CE Mark Study Long Term Follow-up

NCT03022461

Advanced Refractory Left Ventricular Heart Failure

COMPLETED

Children and Adolescents Receiving Mechanical and Prosthetic Valves

NCT00268008

Congenital Disorders

TERMINATED

A Prospective, Multicenter, Observational Study of the Safety and Efficacy of Emergency Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis

NCT07108478

Severe Aortic Valve Stenosis

NOT_YET_RECRUITING

Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction

NCT03667365

Aortic Valve Stenosis

TERMINATED NA

Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS

NCT03094143

Aortic Valve Stenosis Hypertrophy, Left Ventricular

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Valve Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single Arm

Surgical treatment of a diseased, damaged, or malfunctioning aortic valve using SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve surgical replacement device

Aortic Valve Replacement

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

* 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.