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NCT Number: NCT03924661

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Sana - Herzchirurgische Klinik Stuttgart GmbH, Stuttgart, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Rate of total serious valve-related adverse events

    Time frame: 5 Years

    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

  2. Peak gradient as assessed by echocardiography

    Time frame: Up to 5 years

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

  3. Mean gradient as assessed by echocardiography

    Time frame: Up to 5 years

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

  4. Valvular regurgitation as assessed by echocardiography

    Time frame: Up to 5 years

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

Secondary outcomes

  1. Number of all-cause deaths

    Time frame: 1 Year

  2. Number of valve-related deaths

    Time frame: 1 Year

  3. Number of reoperations or explants excluding replacement due to somatic growth

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2026
Study completion
2028
First posted
Apr 23, 2019
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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