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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Valve Disease
• Intervention / Treatment: Device: Aortic Valve Replacement

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany
    • Medizinische Hochschule Hannover
  • Baden-Wurttemberg
    • Stuttgart, Baden-Wurttemberg, Germany, 70174
      • Sana - Herzchirurgische Klinik Stuttgart GmbH
  • Bavaria
    • München, Bavaria, Germany, 80636
      • Deutsches Herzzentrum München des Freistaates Bayern
  • Saxony
    • Leipzig, Saxony, Germany, 04289
      • Herzzentrum Leipzig GmbH
• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles (USC)
    • Madera, California, United States, 93636
      • Valley Children's Hospital
    • Sacramento, California, United States, 95816
      • Sutter Medical Center, Sacramento
  • Florida
    • Miami, Florida, United States, 33155
      • Variety Children's Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children'S Healthcare of Atlanta
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital
  • Texas
    • Austin, Texas, United States, 78723
      • Dell Children's Medical Center
    • Dallas, Texas, United States, 75235
      • Children's Medical Center Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Kyle Brunner, Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (Actual): April 23, 2019

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: ABT-CIP-10237

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No