IntelliStent for Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy (NCT06072937) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
IntelliStent for Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy
10 participantsStarted 2024-06-04
Plain-language summary
IntelliStent is intended to achieve reduction of pulmonary hypertension, improvements in symptoms and quality of life in pediatric, adolescent and adult patients with congenital heart disease associated pulmonary arterial hypertension or left ventricular dilated cardiomyopathy.
Who can participate
Age range12 Years – 60 Years
SexALL
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Inclusion criteria
✓. Age: Adolescent (12-17 years) or Adult (age \>18 years)
✓. Uncorrected CHD (ASD, VSD, PDA, AVSD) with left to right + systemic pulmonary artery pressure or mixed shunting regardless if pulmonary vascular resistance is modifiable or fixed
✓. Diagnosed with WHO Group 1 PH Classification pulmonary hypertension associated with congenital heart disease, evidence by the following parameters measured at rest:
✓. Mean pulmonary artery pressure (mPAP) ≥ 50 mmHg
✓. Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP)
✓. Pulmonary vascular resistance \> 3 Wood Units
✓. Patients with left ventricular dilated cardiomyopathy with symptoms despite optimal medical therapy
✓. Current WHO Functional Class III or IV.
Exclusion criteria
✕. Right ventricular dysfunction
✕. Severe AV valve regurgitation of the pulmonary ventricle
✕. Complex CHD
✕. Ongoing infection
✕. Patients where definitive correction of the CHD is indicated and available as a possible treatment option