Autus Valve Continued Access Study (CAS)
ConditionCongenital Heart Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-16
SponsorEdwards Lifesciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 months to 16 years.
Male or female.
Subject has a native or repaired right ventricular outflow tract.
Subject has been recommended for surgical pulmonary valve replacement by treating clinical team (cardiologist and cardiac surgeon).
Disqualifiers
Subject requires valve replacement in a non-pulmonary position.
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).
Subject has pulmonary arterial hypertension (defined as mean PA pressure ≥25 mmHg).
Subject has a known history of pulmonary atresia and major aortopulmonary collaterals.
Trial design
Design model
Single group
Treatments tested in this trial
Pulmonary Valve Replacement Surgery
DevicePulmonary valve replacement surgery with the Autus Valve
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: Autus Valve ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 reintervention; * Symptomatic thromboembolism.
Time frame
30 Days post-valve implantation2
Primary Effectiveness Endpoint
Acceptable hemodynamic performance at 6 months post-valve implantation, defined as a mean RVOT gradient \<=40 mmHg and less than moderate pulmonary regurgitation by transthoracic echo (TTE) as assessed by the Echocardiography Core Laboratory (ECL), and no Autus Valve reintervention except for valve expansion to address prosthesis-patient mismatch, as assessed by the CEC.
Time frame
6 Months post-valve implantationOther outcomes
1
Other Safety Outcome - Freedom from a device-related complication post-valve implantation - composite
Freedom from a device-related complication post-valve implantation - CEC Adjudicated. The following composite safety outcome will be evaluated at 6 months, and annually through 10 years post-valve implantation. 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 implantation2
Other Safety Outcome -Mortality
The following measure will be evaluated by an independent Clinical Events Committee: • 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 implantation3
Other Safety Outcome - Valve thrombosis
The following measure will be evaluated by an independent Clinical Events Committee: • Valve thrombosis
Time frame
30 days, 6 months and annually through a minimum of 10 years and up to 11 years post-valve implantation4
Other Safety Outcome - Thromboembolism
The following measure will be evaluated by an independent Clinical Events Committee: • Thromboembolism
Time frame
30 days, 6 months and annually through a minimum of 10 years and up to 11 years post-valve implantationSponsors and contacts
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Source ClinicalTrials.gov