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

NCT03924661 | Active Not Recruiting DMC FDA Device

• 1 other identifier: ABT-CIP-10237
• Study Type: observational
• Target: 20
• Locations: 2 countries
• Sites: 13

Brief 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

Outcome Measures

Primary Outcomes (4)

• Rate of total serious valve-related adverse events

  actuarial (Kaplan-Meier) rate of total serious valve-related adverse events experienced through 5 years post implant or until the valve is removed/replaced. Valve-related adverse events to be evaluated are: * Death; * Endocarditis; * Hemorrhage (whether or not due to anticoagulant/antiplatelet medication); * Nonstructural dysfunction (including perivalvular leak, hemolysis, and hemolytic anemia); * Reoperation (including valve explant, not due to anatomical growth of the subject); * Structural valve deterioration; * Thromboembolism * Valvular thrombosis

  5 Years

• Peak gradient as assessed by echocardiography

  Peak gradient as assessed by echocardiography at 30 Days, 6 Months, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year

  Up to 5 years

• Mean gradient as assessed by echocardiography

  Mean gradient as assessed by echocardiography at 30 Days, 6 Months, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year

  Up to 5 years

• Valvular regurgitation as assessed by echocardiography

  Valvular regurgitation as assessed by echocardiography at 30 Days, 6 Months, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year

  Up to 5 years

Secondary Outcomes (3)

• Number of all-cause deaths

  1 Year

• Number of valve-related deaths

  1 Year

• Number of reoperations or explants excluding replacement due to somatic growth

  1 Year

Study Arms (1)

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

Device: Aortic Valve Replacement

Interventions

Aortic Valve Replacement 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

Single Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This clinical study will enroll male and female subjects from the pediatric population. Subjects must meet all eligibility criteria and written and signed informed consent must be obtained from the subject's legal guardian prior to starting the study.

You may qualify if:

• 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).
• 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.

You may not qualify if:

• Subject has a contraindication to anticoagulant/antiplatelet medication.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (13)

Children's Hospital Los Angeles (USC)

Los Angeles, California, 90027, United States

Location

Valley Children's Hospital

Madera, California, 93636, United States

Location

Sutter Medical Center, Sacramento

Sacramento, California, 95816, United States

Location

Variety Children's Hospital

Miami, Florida, 33155, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Dell Children's Medical Center

Austin, Texas, 78723, United States

Location

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

Sana - Herzchirurgische Klinik Stuttgart GmbH

Stuttgart, Baden-Wurttemberg, 70174, Germany

Location

Deutsches Herzzentrum München des Freistaates Bayern

München, Bavaria, 80636, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, Saxony, 04289, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

MeSH Terms

Conditions

Aortic Valve Disease

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Ryan Palmer

  Abbott Medical Devices

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 23, 2019
• Study Start: October 24, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (9); DE (4)