An interventional study of Pulmonary Valve Replacement Surgery in Congenital Heart Disease, sponsored by Edwards Lifesciences. Active, not recruiting at 12 sites in United States. Open to participants aged 18 Months to 16 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Edwards Lifesciences · Not applicable, Interventional, and Treatment
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.
1,007 studies on the registry are indexed under Heart Defects, Congenital; 257 are open to participants now.
This study's enrollment of 62 is close to the median of 60 across 524 interventional studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Edwards Lifesciences is the lead sponsor of 124 studies on the registry; 19 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 32 (94%) have results posted.
Counted across the registry records on this site, refreshed daily.
Candidates must meet all of the following inclusion criteria to be considered for enrollment in this study.
Subject has at least one of the following echocardiographic findings:
Exclusion Criteria:
Candidates will be excluded from the study if any of the following conditions are met:
Pulmonary Valve Replacement Surgery with the Autus Valve
Device: Pulmonary Valve Replacement Surgery
Pulmonary valve replacement surgery with the Autus Valve
Valve Implantation Primary Safety Endpoint
Composite Endpoint: Freedom from a device-related complication through 30 days post-valve implantation as adjudicated by an independent Clinical Events Committee (CEC), including: * Death; * Valve thrombosis requiring intervention; * Symptomatic thromboembolism.
Time frame: 30 Days post-valve implantation
Valve Implantation Primary Effectiveness Endpoint
Acceptable hemodynamic performance at 6 months post-valve implantation, as assessed by the Echocardiography Core Laboratory or Clinical Events Committee, defined as: * A mean RVOT gradient less than or equal to 40 mmHg and * Less than moderate pulmonary regurgitation by transthoracic echo and * No Autus Valve reintervention except for valve expansion to address prosthesis-patient mismatch.
Time frame: 6 Months post-valve implantation
Other Safety Outcome - Composite
The following other safety outcome will be evaluated at 6 months, and annually through 10 years post-valve implantation by an independent Clinical Events Committee. The composite outcome includes device-related: * Death; * Valve thrombosis requiring intervention; * Symptomatic thromboembolism.
Time frame: 6 months and annually through a minimum of 10 years and up to 11 years post-valve implantation
Other Safety Outcome - Mortality
The following measure will be evaluated by an independent Clinical Events Committee at 30 days, 6 months, and annually through 10 years post-valve implantation. Subjects that undergo valve expansion in year 10 after device implantation will be followed for an additional year. • Mortality, including: all cause, cardiac-related, procedure-related and device-related
Time frame: 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation
Other Safety Outcome - Valve Thrombosis
The following measure will be evaluated by an independent Clinical Events Committee at 30 days, 6 months, and annually through 10 years post-valve implantation. Subjects that undergo valve expansion in year 10 after device implantation will be followed for an additional year. • Valve thrombosis
Time frame: 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation
Other Safety Outcome - Thromboembolism
The following measure will be evaluated by an independent Clinical Events Committee at 30 days, 6 months, and annually through 10 years post-valve implantation. Subjects that undergo valve expansion in year 10 after device implantation will be followed for an additional year. • Thromboembolism
Time frame: 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation
Other Safety Outcome - Cardiac or Valve Intervention
The following measure will be evaluated by an independent Clinical Events Committee at 30 days, 6 months, and annually through 10 years post-valve implantation. Subjects that undergo valve expansion in year 10 after device implantation will be followed for an additional year. • Other cardiac or valve intervention (surgical or transcatheter)
Time frame: 30 days, 6 months, and annually through a minimum of 510 years and up to 11 years post-valve implantation
Other Safety Outcome - Major Hemorrhage
The following measure will be evaluated by an independent Clinical Events Committee at 30 days, 6 months, and annually through 10 years post-valve implantation. Subjects that undergo valve expansion in year 10 after device implantation will be followed for an additional year. • Major hemorrhage
Time frame: 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation
Other Safety Outcome - Endocarditis
The following measure will be evaluated by an independent Clinical Events Committee at 30 days, 6 months, and annually through 10 years post-valve implantation. Subjects that undergo valve expansion in year 10 after device implantation will be followed for an additional year. • Endocarditis
Time frame: 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation
Other Safety Outcome - Hemolysis
The following measure will be evaluated by an independent Clinical Events Committee at 30 days, 6 months, and annually through 10 years post-valve implantation. Subjects that undergo valve expansion in year 10 after device implantation will be followed for an additional year. • Hemolysis
Time frame: 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation
Other Safety Outcome - Device Explantation
The following measure will be evaluated by an independent Clinical Events Committee at 30 days, 6 months, and annually through 10 years post-valve implantation. Subjects that undergo valve expansion in year 10 after device implantation will be followed for an additional year. • Device explantation
Time frame: 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation
Other Safety Outcome - Adverse Events (AE)
The following measure will be reported at 30 days, 6 months, and annually through 10 years post-valve implantation. Subjects that undergo valve expansion in year 10 after device implantation will be followed for an additional year. • Adverse events
Time frame: 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation
Other Safety Outcome - Valve/Stent Fracture
An independent Medical Reviewer will review post-implant chest x-rays to assess for valve/stent fracture. Chest x-rays will be performed at the following timepoints: post-valve implantation at hospital discharge, and annually through 5 years post-valve implantation. If a post-implant valve expansion procedure is performed, chest x-rays will be performed at hospital discharge and 12 months post-procedure.
Time frame: 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.
Other Effectiveness Outcome - Valve Implant Acute Procedural Success
To meet the definition of success, all the parameters listed below must be achieved, as assessed by Sites using direct pressure measurements and/or transesophageal echo (TEE): * RV to PA peak systolic pressure gradient \<40 mmHg (direct pressure measurement); * None or trivial pulmonary regurgitation (assessed via TEE); * No paravalvular leak (assessed via TEE).
Time frame: Immediately Post-Valve Implant Procedure
Other Effectiveness Outcome - Pulmonary Regurgitation Grade
Pulmonary regurgitation grade categorized as none, trivial, mild, moderate, severe as evaluated by the Echo Core Laboratory.
Time frame: Baseline, 30 days, 6 months, and annually through 10 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.
Other Effectiveness Outcome - Pulmonary Stenosis Grade
Pulmonary stenosis grade categorized as none/trivial, mild, moderate, severe, as evaluated by the Echo Core Laboratory.
Time frame: Baseline, 30 days, 6 months, and annually through 10 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.
Other Effectiveness Outcome - Right Ventricular Measures
Right ventricular (RV) measures, including RV dimension and strain will be evaluated by the Echo Core Laboratory.
Time frame: Baseline, 30 days, 6 months, and annually through 5 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.
Other Effectiveness Outcome - Left Ventricular Measures
Left ventricular (LV) measures, including LV ejection fraction and strain will be evaluated by the Echo Core Laboratory.
Time frame: Baseline, 30 days, 6 months, and annually through 10 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.
Other Effectiveness Outcome - Modified Ross Functional Classification
Modified Ross Functional Class as assessed by the Site Investigators
Time frame: Baseline, 30 days, 6 months, and annually through 10 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.
Other Effectiveness Outcome - PedsQL - Cardiac Module
The Pediatric Qualify of Life Inventory (PedsQL) Cardiac Module will be administered by Site Personnel.
Time frame: 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.
Other Post-Implant Valve Expansion Safety Outcome - Composite
Composite Endpoint: Freedom from device-related complication through 30 days post-valve expansion as adjudicated by an independent CEC: * Death; * Extracorporeal membrane oxygenation (ECMO) support; * Unplanned intervention (surgical or transcatheter); * Major hemorrhage
Time frame: 30 days after each post-implant valve expansion procedure
Other Post-Implant Valve Expansion Effectiveness Outcome - Acute Procedural Success
To meet the definition of success, at least one of the parameters listed below must be achieved after each post-implant valve expansion is performed, assessed during the same catheterization procedure: * RV to aortic systolic pressure ratio: ≤0.5. * Peak-to-peak RV to PA systolic pressure gradient: ≤15 mmHg; * Peak-to-peak RV to PA systolic pressure gradient: ≥50% reduction (pre vs post valve expansion).
Time frame: Immediately after each post-implant valve expansion procedure
Other Post-Implant Valve Expansion Effectiveness Outcome - Hemodynamic Performance
Clinically acceptable hemodynamic performance at 6 months post-valve expansion procedure, as assessed by the Echo Core Laboratory via TTE, defined as: * Less than moderate pulmonary regurgitation (PR) by Doppler echocardiography; * Transvalvular gradient (assessed by CW Doppler) at 6-months is lower than the pre-expansion gradient.
Time frame: 6 months after each post-implant valve expansion procedure
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Edwards Lifesciences