A Single Arm, Non-randomized, Multi-center Clinical Study of the SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy

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

Sponsors

Lead sponsor: Abbott Medical Devices

Source 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.

Overall Status Recruiting
Start Date October 24, 2019
Completion Date February 2028
Primary Completion Date June 2023
Study Type Observational
Primary Outcome
Measure Time Frame
Rate of total serious valve-related adverse events 5 Years
Peak gradient as assessed by echocardiography Up to 5 years
Mean gradient as assessed by echocardiography Up to 5 years
Valvular regurgitation as assessed by echocardiography Up to 5 years
Secondary Outcome
Measure Time Frame
Number of all-cause deaths 1 Year
Number of valve-related deaths 1 Year
Number of reoperations or explants excluding replacement due to somatic growth 1 Year
Enrollment 20
Condition
Intervention

Intervention type: Device

Intervention name: Aortic Valve Replacement

Description: 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

Arm group label: Single Arm

Eligibility

Sampling method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
John Carrithers Study Director Abbott Medical Devices
Overall Contact

Last name: Deja Fercho

Phone: 651-756-4504

Email: [email protected]

Location
facility status contact investigator
Children's Hospital Los Angeles (USC) | Los Angeles, California, 90027, United States Recruiting Ruth Lemus [email protected] Cynthia Herrington, MD Principal Investigator
Valley Children's Hospital | Madera, California, 93636, United States Not yet recruiting Tamanjit Basi 559-353-5342 [email protected] Malcom Macdonald, MD Principal Investigator
Sutter Medical Center, Sacramento | Sacramento, California, 95819, United States Not yet recruiting Beverly Seiler [email protected] Teimour Nasirov, MD Principal Investigator
Variety Children's Hospital | Miami, Florida, 33155, United States Recruiting Kay Salinas 305-624-2425 [email protected] Redmond Burke, MD Principal Investigator
Children's Healthcare of Atlanta | Atlanta, Georgia, 30322, United States Recruiting Nikita Rao [email protected] Kirk Kanter, MD Principal Investigator
University of Mississippi Medical Center | Jackson, Mississippi, 39216, United States Recruiting Emilee Taylor 601-815-9422 [email protected] Brian Kogon, MD Principal Investigator Mohammed Ghanamah, MD Sub-Investigator
Cincinnati Children's Hospital | Cincinnati, Ohio, 45229, United States Recruiting Tricia Heile [email protected] David Morales, MD Principal Investigator
Location Countries

United States

Verification Date

December 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Arm Group

Arm group label: Single Arm

Description: 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

Study Design Info

Observational model: Cohort

Time perspective: Cross-Sectional

Source: ClinicalTrials.gov