RECRUITING

Autus Valve Pivotal Study

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Autus Size-Adjustable Valve for Surgical Pulmonary Valve Replacement Pivotal Study

Quick Facts

Study Start:2024-02-05

Study Completion:2036-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05006404

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Months to 16 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
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.	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.

Inclusion Criteria

Exclusion Criteria

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.

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.

Contacts and Locations

Study Contact

Sophie-Charlotte Hofferberth, MD.

CONTACT

617-390-6468

shofferberth@autusvalve.com

Paul Mehoudar, M.S.

CONTACT

510-409-2255

pmehoudar@yahoo.com

Principal Investigator

Sophie-Charlotte Hofferberth, MD

STUDY_DIRECTOR

Autus Valve Technologies, Inc.

Study Locations (Sites)

Children's Hospital Los Angeles

Los Angeles, California, 90027

United States

Children's Hospital Colorado

Aurora, Colorado, 80045

United States

Ann and Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611

United States

Boston Children's Hospital

Boston, Massachusetts, 02115

United States

University of Michigan - Mott Children's Hospital

Ann Arbor, Michigan, 48109

United States

Columbia University Irving Medical Center/New York Presbyterian Morgan Stanley Children's Hospital

New York, New York, 10032

United States

Duke University

Durham, North Carolina, 27703

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Seattle Children's Hospital

Seattle, Washington, 98105

United States

Collaborators and Investigators

Sponsor: Autus Valve Technologies, Inc.

Sophie-Charlotte Hofferberth, MD, STUDY_DIRECTOR, Autus Valve Technologies, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-05

Study Completion Date2036-02

Study Record Updates

Study Start Date2024-02-05

Study Completion Date2036-02

Terms related to this study

Additional Relevant MeSH Terms

Congenital Heart Disease