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PIVOTAL STUDY OVERVIEW

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50 PATIENTS

18 MONTHS TO 16 YEARS OF AGE

Patients aged 18 months to 16 years requiring pulmonary valve replacement

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*Inclusion and Exclusion Criteria apply.

UP TO 15 U.S. CENTERS

KEY INCLUSION CRITERIA*

  • Aged 18 months to 16 years

  • Subject has a native or repaired right ventricular outflow tract.

  • Subject has at least one of the following echocardiographic findings:

    1. Severe pulmonary stenosis (defined as RV to PA peak instantaneous gradient ≥60 mmHg);

    2. Moderate or greater pulmonary regurgitation

    3. Moderate or greater pulmonary stenosis plus moderate or greater pulmonary regurgitation.

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KEY EXCLUSION CRITERIA*

  • 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 pulmonary atresia and major aortopulmonary collaterals.

  • Subject has significant peripheral pulmonary artery stenosis.

  • Subject has a known hypersensitivity to anticoagulants and antiplatelet drugs.

*DISCLAIMER: This is only a selection of key criteria. Please consult the participating study centers or clinical trials.gov for more information.

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For full study information please visit:

http://clinicaltrials.gov Study Number NCT05006404. 

CAUTION: ­­ Investigational device. Limited by Federal (United States) law to investigational use.

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