Autus Valve Continued Access Study (CAS)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Autus Valve Technologies, Inc.
Study ID
NCT07466745
Status
Not Yet Recruiting

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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

Start date
Apr 15, 2026
Status verified
Mar 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-
Children's Hospital ColoradoAuroraColorado80045-
Children's Healthcare of AtlantaAtlantaGeorgia30322-
Boston Children's HospitalBostonMassachusetts02115-
University of Michigan - Mott Children's HospitalAnn ArborMichigan48109-
Columbia University Irving Medical Center/New York Presbyterian Morgan Stanley Children's HospitalNew YorkNew York10032-
Duke UniversityDurhamNorth Carolina27703-
Nationwide Children's HospitalColumbusOhio43205-
University of Utah - Intermountain Primary Children's HospitalSalt Lake CityUtah84113-
Seattle Children's HospitalSeattleWashington98105-

Find similar trials in Los Angeles, CA

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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