SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
- Conditions
- Aortic Valve Disease
- Interventions
- Device: Aortic Valve Replacement
- Registration Number
- NCT03924661
- Lead Sponsor
- Abbott Medical Devices
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
-
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 for prospectively enrolled subjects:
Subject has a contraindication to anticoagulant/antiplatelet medication.
- Exclusion criteria of retrospectively enrolled subjects: None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Single Arm Aortic Valve Replacement 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
- Primary Outcome Measures
Name Time Method Peak gradient as assessed by echocardiography 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
Valvular regurgitation as assessed by echocardiography 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
Rate of total serious valve-related adverse events 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 thrombosisMean gradient as assessed by echocardiography 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
- Secondary Outcome Measures
Name Time Method Number of valve-related deaths 1 Year Number of all-cause deaths 1 Year Number of reoperations or explants excluding replacement due to somatic growth 1 Year
Trial Locations
- Locations (13)
Deutsches Herzzentrum München des Freistaates Bayern
🇩🇪München, Bavaria, Germany
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Variety Children's Hospital
🇺🇸Miami, Florida, United States
Children's Hospital Los Angeles (USC)
🇺🇸Los Angeles, California, United States
Valley Children's Hospital
🇺🇸Madera, California, United States
Children's Medical Center Dallas
🇺🇸Dallas, Texas, United States
Sana - Herzchirurgische Klinik Stuttgart GmbH
🇩🇪Stuttgart, Baden-Wurttemberg, Germany
Herzzentrum Leipzig GmbH
🇩🇪Leipzig, Saxony, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Sutter Medical Center, Sacramento
🇺🇸Sacramento, California, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Dell Children's Medical Center
🇺🇸Austin, Texas, United States