Clinical trialNCT07466745RecruitingInterventional

Autus Valve Continued Access Study (CAS)

SponsorEdwards LifesciencesEnrollment36Congenital Heart Disease

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

No overall officials are registered on this study record. Site-level investigators, where published, appear with their sites below. Why? →

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

10 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Children'S Hospital Los Angeles
Los Angeles, California, United States
Darren Berman, MDLuke Wiggins, MD
Not, yet, recruiting
Children'S Hospital Colorado
Aurora, Colorado, United States
Gareth Morgan, MDJames Jaggers, MD
Not, yet, recruiting
Children'S Healthcare of Atlanta
Atlanta, Georgia, United States
Dennis Kim, MDPaul Chai, MD
Not, yet, recruiting
Boston Children'S Hospital
Boston, Massachusetts, United States
Christopher Baird, MDDiego Porras, MDEric Feins, MDNicola Maschietto, MD
Not, yet, recruiting
University of Michigan - Mott Children'S Hospital
Ann Arbor, Michigan, United States
Jeffrey Zampi, MDJennifer Romano, MD
Recruiting
Columbia University Irving Medical Center/new York Presbyterian Morgan Stanley Children'S Hospital
New York, New York, United States
Emile Bacha, MDOliver Barry, MD
Not, yet, recruiting
Duke University
Durham, North Carolina, United States
Gregory Fleming, MDJoseph Turek, MD
Not, yet, recruiting
Nationwide Children'S Hospital
Columbus, Ohio, United States
Aimee Armstrong, MDMark Galantowicz, MD
Not, yet, recruiting
University of Utah - Intermountain Primary Children'S Hospital
Salt Lake City, Utah, United States
Mary Martin, MDS. Adil Husain, MD
Not, yet, recruiting
Seattle Children'S Hospital
Seattle, Washington, United States
Brian Morray, MDChristina Greene, MD
Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 27 Jul 2026
Primary completion: 30 Oct 2027
Completion: 30 Apr 2036
Last update posted: 10 Aug 2026
Registered enrollment: 36
Registry id: NCT07466745

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.