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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03924661
Other study ID # ABT-CIP-10237
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 24, 2019
Est. completion date October 2028

Study information

Verified date February 2024
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 malfunctioning aortic valve.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date October 2028
Est. primary completion date June 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany Medizinische Hochschule Hannover Hannover
Germany Herzzentrum Leipzig GmbH Leipzig Saxony
Germany Deutsches Herzzentrum München des Freistaates Bayern München Bavaria
Germany Sana - Herzchirurgische Klinik Stuttgart GmbH Stuttgart Baden-Wurttemberg
United States Children's Healthcare of Atlanta Atlanta Georgia
United States Dell Children's Medical Center Austin Texas
United States Cincinnati Children's Hospital Cincinnati Ohio
United States Children's Medical Center Dallas Dallas Texas
United States University of Mississippi Medical Center Jackson Mississippi
United States Children's Hospital Los Angeles (USC) Los Angeles California
United States Valley Children's Hospital Madera California
United States Variety Children's Hospital Miami Florida
United States Sutter Medical Center, Sacramento Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 Number of all-cause deaths 1 Year
Secondary Number of valve-related deaths 1 Year
Secondary Number of reoperations or explants excluding replacement due to somatic growth 1 Year
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