Autus Valve Continued Access Study (CAS)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Edwards Lifesciences
Study ID
NCT07466745
Status
Recruiting
Apply to this trial

Conditions

  • Congenital Heart Disease

Eligibility Criteria

Sex
ALL
Age
18 Months - 16 Years
Healthy Volunteers
Not accepted

Interventions

  • Pulmonary Valve Replacement Surgery — DEVICE
    Pulmonary valve replacement surgery with the Autus Valve

Study Details

Prospective, single-arm, multi-center, continued access study 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-implantation, 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.

Key Dates

First listed
Mar 12, 2026
Start date
Jul 27, 2026
Status verified
Aug 2026
Primary completion
Oct 30, 2027
Completion
Apr 30, 2036

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Autus Valve Arm
    Pulmonary Valve Replacement Surgery with the Autus Valve

Primary Outcome Measure

Primary Safety Endpoint [ Time Frame: 30 Days post-valve implantation ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027
Research Coordinator
[email protected]
612-351-7835
Luke Wiggins, MD (PRINCIPAL_INVESTIGATOR)
Darren Berman, MD (SUB_INVESTIGATOR)
Children's Hospital ColoradoAuroraColorado80045
Research Coordinator
[email protected]
720-777-0478
James Jaggers, MD (PRINCIPAL_INVESTIGATOR)
Gareth Morgan, MD (SUB_INVESTIGATOR)
Children's Healthcare of AtlantaAtlantaGeorgia30322
Research Coordinator
[email protected]
404-785-4795
Paul Chai, MD (PRINCIPAL_INVESTIGATOR)
Dennis Kim, MD (SUB_INVESTIGATOR)
Boston Children's HospitalBostonMassachusetts02115
Research Coordinator
[email protected]
617-919-4457
Christopher Baird, MD (PRINCIPAL_INVESTIGATOR)
Diego Porras, MD (PRINCIPAL_INVESTIGATOR)
Nicola Maschietto, MD (SUB_INVESTIGATOR)
Eric Feins, MD (SUB_INVESTIGATOR)
University of Michigan - Mott Children's HospitalAnn ArborMichigan48109
Research Coordinator
[email protected]
734-647-9038
Jennifer Romano, MD (PRINCIPAL_INVESTIGATOR)
Jeffrey Zampi, MD (SUB_INVESTIGATOR)
Columbia University Irving Medical Center/New York Presbyterian Morgan Stanley Children's HospitalNew YorkNew York10032
Research Coordinator
[email protected]
212-342-1562
Oliver Barry, MD (PRINCIPAL_INVESTIGATOR)
Emile Bacha, MD (SUB_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27703
Research Coordinator
[email protected]
919-684-1988
Joseph Turek, MD (PRINCIPAL_INVESTIGATOR)
Gregory Fleming, MD (SUB_INVESTIGATOR)
Nationwide Children's HospitalColumbusOhio43205
Research Coordinator
[email protected]
614-355-5763
Mark Galantowicz, MD (PRINCIPAL_INVESTIGATOR)
Aimee Armstrong, MD (PRINCIPAL_INVESTIGATOR)
University of Utah - Intermountain Primary Children's HospitalSalt Lake CityUtah84113
Research Coordinator
[email protected]
801-587-7523
S. Adil Husain, MD (PRINCIPAL_INVESTIGATOR)
Mary Martin, MD (PRINCIPAL_INVESTIGATOR)
Seattle Children's HospitalSeattleWashington98105
Research Coordinator
[email protected]
206-987-6580
Brian Morray, MD (PRINCIPAL_INVESTIGATOR)
Christina Greene, MD (SUB_INVESTIGATOR)

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By research site
Children's Hospital Los Angeles· Los Angeles, CAChildren's Hospital Colorado· Aurora, COChildren's Healthcare of Atlanta· Atlanta, GABoston Children's Hospital· Boston, MAUniversity of Michigan - Mott Children's Hospital· Ann Arbor, MIColumbia University Irving Medical Center/New York Presbyterian Morgan Stanley Children's Hospital· New York, NY

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