Clinical trial NCT05006404: Autus Valve Pivotal Study
Official title: Autus Size-Adjustable Valve for Surgical Pulmonary Valve Replacement Pivotal Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Lead sponsor: Autus Valve Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, single-arm, multi-center study to evaluate safety and effectiveness of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement. The Autus Valve may be expanded pre-implant to match the subject's body size. Subjects will be evaluated prior to the Autus Valve implant procedure, immediately post-implant, at hospital discharge, 30 days, 6 months, and annually through 10 years.

The Autus Valve may be expanded post-implant via transcatheter balloon dilation to accommodate growth of the subject. In subjects who undergo a post-implant valve expansion, follow-up will continue for a minimum of 1 year after the post-implant valve expansion procedure.


Eligibility criteria: Inclusion Criteria:

Candidates must meet all of the following inclusion criteria to be considered for enrollment in this study.

1. Age 18 months to 16 years.
2. Male or female.
3. Subject has a native or repaired right ventricular outflow tract.
4. Subject has been recommended for surgical pulmonary valve replacement by treating clinical team (cardiologist and cardiac surgeon).
5. Subject has at least one of the following echocardiographic findings:

   1. Severe pulmonary stenosis (defined as RV to PA peak instantaneous gradient ≥60 mmHg);
   2. Moderate or greater pulmonary regurgitation;
   3. Moderate or greater pulmonary stenosis plus moderate or greater pulmonary regurgitation.
6. Subject's body size is suitable for implantation of a study device ranging from 12.7 to 22 mm (internal diameter).
7. Subject and parent/legal representative, where appropriate, are willing to provide informed written consent.
8. Subject and parent/legal representative, where appropriate, and treating physician agree that the subject will return for, and comply with, all required study assessments and follow-up visits.

Exclusion Criteria:

Candidates will be excluded from the study if any of the following conditions are met:

1. Subject requires valve replacement in a non-pulmonary position.
2. Subject has a prosthetic valve at other valve position or will need a prosthetic valve at other valve position (i.e., anticipate additional valve replacements needed within 3 years).
3. Subject has pulmonary arterial hypertension (defined as mean PA pressure ≥25 mmHg).
4. Subject has pulmonary atresia and major aortopulmonary collaterals.
5. Subject has significant peripheral pulmonary artery stenosis.
6. Subject has an active infection requiring current systemic antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics).
7. Subject has active endocarditis or a history of infective endocarditis.
8. Subject has renal insufficiency as determined by a serum creatinine (S-Cr) level ≥2.5 mg/dL within 60 days prior to the Screening Visit, or has end-stage renal disease.
9. Subject has leukopenia (defined as a white blood cell (WBC) count \<3.5 x 103/µL)
10. Subject has acute or chronic anemia (defined as hemoglobin (Hgb) \<10.0 g/dl or 6 mmol/L).
11. Subject has thrombocytopenia (defined as platelet count \<50 x 103/µL.
12. Subject has a known hypersensitivity to anticoagulants and antiplatelet drugs.
13. Subject has a known autoimmune disease or receives immunosuppressant and/or immunostimulant drugs that the Investigator or Eligibility Screening Committee (ESC) believes may negatively affect study outcomes.
14. Subject needs emergency cardiac or vascular surgery or intervention.
15. Positive pregnancy test prior to valve implant procedure in female subjects who have had their first menses.
16. Subject has, in the opinion of the Investigator, a life expectancy of less than 5 years.
17. Subject or parent/legal representative refuses blood transfusions.
18. Subject has medical, social or psychosocial factors that, in the opinion of the Investigator or ESC, could impact safety or compliance with study procedures.
19. Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening.

Primary outcomes:
measure: Valve Implantation Primary Safety Endpoint
timeFrame: 30 Days post-valve implantation
measure: Valve Implantation Primary Effectiveness Endpoint
timeFrame: 6 Months post-valve implantation
Secondary outcomes:
Other outcomes:
measure: Other Safety Outcome - Composite
timeFrame: 6 months and annually through a minimum of 10 years and up to 11 years post-valve implantation
measure: Other Safety Outcome - Mortality
timeFrame: 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation
measure: Other Safety Outcome - Valve Thrombosis
timeFrame: 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation
measure: Other Safety Outcome - Thromboembolism
timeFrame: 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation
measure: Other Safety Outcome - Cardiac or Valve Intervention
timeFrame: 30 days, 6 months, and annually through a minimum of 510 years and up to 11 years post-valve implantation
measure: Other Safety Outcome - Major Hemorrhage
timeFrame: 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation
measure: Other Safety Outcome - Endocarditis
timeFrame: 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation
measure: Other Safety Outcome - Hemolysis
timeFrame: 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation
measure: Other Safety Outcome - Device Explantation
timeFrame: 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation
measure: Other Safety Outcome - Adverse Events (AE)
timeFrame: 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation
measure: Other Safety Outcome - Valve/Stent Fracture
timeFrame: pre-discharge, 12 months, and annually through a minimum of 5 years and up to 6 years post-valve implantation. Subjects that undergo post-implant valve expansion will be evaluated pre-discharge and at 12 months post-valve expansion.
measure: Other Effectiveness Outcome - Valve Implant Acute Procedural Success
timeFrame: Immediately Post-Valve Implant Procedure
measure: Other Effectiveness Outcome - Pulmonary Regurgitation Grade
timeFrame: Baseline, 30 days, 6 months, and annually through 10 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.
measure: Other Effectiveness Outcome - Pulmonary Stenosis Grade
timeFrame: Baseline, 30 days, 6 months, and annually through 10 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.
measure: Other Effectiveness Outcome - Right Ventricular Measures
timeFrame: Baseline, 30 days, 6 months, and annually through 5 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.
measure: Other Effectiveness Outcome - Left Ventricular Measures
timeFrame: Baseline, 30 days, 6 months, and annually through 10 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.
measure: Other Effectiveness Outcome - Modified Ross Functional Classification
timeFrame: Baseline, 30 days, 6 months, and annually through 10 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.
measure: Other Effectiveness Outcome - PedsQL - Cardiac Module
timeFrame: Baseline, 6 months and annually through 10 years post-valve implantation. Subjects that undergo post-implant valve expansion will be evaluated pre-valve expansion, and at 6 and 12 months post-valve expansion.
measure: Other Post-Implant Valve Expansion Safety Outcome - Composite
timeFrame: 30 days after each post-implant valve expansion procedure
measure: Other Post-Implant Valve Expansion Effectiveness Outcome - Acute Procedural Success
timeFrame: Immediately after each post-implant valve expansion procedure
measure: Other Post-Implant Valve Expansion Effectiveness Outcome - Hemodynamic Performance
timeFrame: 6 months after each post-implant valve expansion procedure
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Ann and Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan - Mott Children's Hospital
state: Michigan
city: New York
country: United States
facility: Columbia University Irving Medical Center/New York Presbyterian Morgan Stanley Children's Hospital
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah - Intermountain Primary Children's Hospital
state: Utah
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Autus Valve Technologies, Inc.
name: Sophie-Charlotte Hofferberth, MD
role: STUDY_DIRECTOR
References: