Aortic Valve DiseaseNCT03924661
SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
An observational study of Aortic Valve Disease, run by Abbott Medical Devices at 13 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- Aortic Valve Replacement
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 24 Oct 2019to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- Subject has a contraindication to anticoagulant/antiplatelet medication.
- Exclusion criteria of retrospectively enrolled subjects: None
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States9 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Dell Children's Medical Center
Austin, Texas, 78723
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Children's Medical Center Dallas
Dallas, Texas, 75235
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Children's Hospital Los Angeles (USC)
Los Angeles, California, 90027
Valley Children's Hospital
Madera, California, 93636
Variety Children's Hospital
Miami, Florida, 33155
Sutter Medical Center, Sacramento
Sacramento, California, 95816
Germany4 sites
Medizinische Hochschule Hannover
Hanover
Herzzentrum Leipzig GmbH
Leipzig, Saxony, 04289
Deutsches Herzzentrum München des Freistaates Bayern
München, Bavaria, 80636
Sana - Herzchirurgische Klinik Stuttgart GmbH
Stuttgart, Baden-Wurttemberg, 70174
About this study
Official 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
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
- Being tested
- Aortic Valve Replacement
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic Valve ReplacementDevice
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Aortic Valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 5 years
Secondary outcomes (3)
Number of all-cause deaths
Measured: 1 Year
Number of valve-related deaths
Measured: 1 Year
Number of reoperations or explants excluding replacement due to somatic growth
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start24 Oct 2019
- Primary completionJun 2026 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ryan Palmer, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924661
- Sponsor's protocol ID
- ABT-CIP-10237
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2019
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03924661
- Acronym / sponsor ID
- ABT-CIP-10237
- Conditions
- Aortic Valve Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | – | Device: Aortic Valve ReplacementSurgical treatment of a diseased, damaged, or malfunctioning aortic valve using SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve surgical replacement device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (2 listed)
- Subject has a contraindication to anticoagulant/antiplatelet medication.
- Exclusion criteria of retrospectively enrolled subjects: None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aortic Valve ReplacementSJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve as a replacement device for patients with a diseased, damaged, or malfunctioning aortic valve | Device | Single Arm |
Primary outcome
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
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
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
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
3 secondary outcomes
Number of all-cause deaths
Time frame: 1 Year
Number of valve-related deaths
Time frame: 1 Year
Number of reoperations or explants excluding replacement due to somatic growth
Time frame: 1 Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Palmer study director
Abbott Medical Devices
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease, run by Abbott Medical Devices at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of total serious valve-related adverse events (time frame: 5 Years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.