top of page

PIVOTAL STUDY OVERVIEW

Kid Playing with Bubble
Young kids
Top View of Kids Playing

50 PATIENTS

         

18 MONTHS TO 16 YEARS OF AGE

Patients aged 18 months to 16 years requiring pulmonary valve replacement

*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.

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.

For full study information please visit:

http://clinicaltrials.gov Study Number NCT05006404. 

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

bottom of page