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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03924661

Recruitment Status Recruiting

First Posted April 23, 2019

Last update posted January 13, 2021

Study Description

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.

  • Condition or Disease:Aortic Valve Disease
  • Intervention/Treatment: Device: Aortic Valve Replacement
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 20 participants
  • Observational Model: Cohort
  • Time Perspective: Cross-Sectional
  • 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
  • Actual Study Start Date: October 2019
  • Estimated Primary Completion Date: June 2023
  • Estimated Study Completion Date: February 2028
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Single Arm
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
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
Outcome Measures
  • Primary Outcome Measures: 1. Rate of total serious valve-related adverse events [ Time Frame: 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 thrombosis
  • 2. Peak gradient as assessed by echocardiography [ Time Frame: 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
  • 3. Mean gradient as assessed by echocardiography [ Time Frame: 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
  • 4. Valvular regurgitation as assessed by echocardiography [ Time Frame: 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
  • Secondary Outcome Measures: 1. Number of valve-related deaths [ Time Frame: 1 Year ]
  • 2. Number of reoperations or explants excluding replacement due to somatic growth [ Time Frame: 1 Year ]
  • 3. Number of all-cause deaths [ Time Frame: 1 Year ]
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • 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.
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

Contacts and Locations
Contacts

Contact: Cathy Sonmore 651-756-5582 cathy.sonmore@abbott.com

Locations

United States, California
Children's Hospital Los Angeles (USC)
Los Angeles

United States, California
Valley Children's Hospital
Madera

United States, California
Sutter Medical Center, Sacramento
Sacramento

United States, Florida
Variety Children's Hospital
Miami

United States, Georgia
Children's Healthcare of Atlanta
Atlanta

United States, Mississippi
University of Mississippi Medical Center
Jackson

United States, Ohio
Cincinnati Children's Hospital
Cincinnati

Sponsors and Collaborators

Abbott Medical Devices

Investigators

Study Director: John Carrithers, PhD Abbott Medical Devices

More Information
  • Responsible Party: Abbott Medical Devices
  • ClinicalTrials.gov Identifier: NCT03924661 History of Changes
  • Other Study ID Numbers: ABT-CIP-10237
  • First Posted: April 23, 2019 Key Record Dates
  • Last Update Posted: January 13, 2021
  • Last Verified: January 2021
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Product Manufactured in and Exported from the U.S.: Yes