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

Aortic Valve Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03924661
• Other study ID #: ABT-CIP-10237
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Aortic Valve Disease

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