Clinical trial NCT03924661: SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aortic Valve Disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2019-04-23
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility 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

Primary outcomes:
measure: Rate of total serious valve-related adverse events
timeFrame: 5 Years
measure: Peak gradient as assessed by echocardiography
timeFrame: Up to 5 years
measure: Mean gradient as assessed by echocardiography
timeFrame: Up to 5 years
measure: Valvular regurgitation as assessed by echocardiography
timeFrame: Up to 5 years
Secondary outcomes:
measure: Number of all-cause deaths
timeFrame: 1 Year
measure: Number of valve-related deaths
timeFrame: 1 Year
measure: Number of reoperations or explants excluding replacement due to somatic growth
timeFrame: 1 Year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles (USC)
state: California
city: Madera
country: United States
facility: Valley Children's Hospital
state: California
city: Sacramento
country: United States
facility: Sutter Medical Center, Sacramento
state: California
city: Miami
country: United States
facility: Variety Children's Hospital
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Austin
country: United States
facility: Dell Children's Medical Center
state: Texas
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
city: Stuttgart
country: Germany
facility: Sana - Herzchirurgische Klinik Stuttgart GmbH
state: Baden-Wurttemberg
city: München
country: Germany
facility: Deutsches Herzzentrum München des Freistaates Bayern
state: Bavaria
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
state: Saxony
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
Study officials:
affiliation: Abbott Medical Devices
name: Ryan Palmer
role: STUDY_DIRECTOR
References: