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.

IntelliStent Implant System is a kit of stents for adjustable interventional reduction of blood flow through a novel and minimally invasive intervention to replace surgical Pulmonary Artery Banding (PAB).

Inclusion Criteria:

1. Age: Adolescent (12-17 years) or Adult (age >18 years)

2. 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

3. Diagnosed with WHO Group 1 PH Classification pulmonary hypertension associated with congenital heart disease, evidence by the following parameters measured at rest:

   1. Mean pulmonary artery pressure (mPAP) ≥ 50 mmHg

   2. Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP)

      ≤ 15 mmHg.

   3. Pulmonary vascular resistance > 3 Wood Units

4. Patients with left ventricular dilated cardiomyopathy with symptoms despite optimal medical therapy

5. Current WHO Functional Class III or IV.

6. Patients with the following anatomical dimensions (gated CT with angio or MRI with EKG) at target implantation site:

   1. MPA diameter @ systolic ≥ 15 mm and ≤ 24 mm and length @ systolic ≥ 28 mm, or
   2. Left and Right PA Branch diameter @ systolic ≥ 15 mm and ≤ 24 mm and length @ systolic ≥ 28 mm

7. Main pulmonary artery (MPA) or left/right PA Branch anatomy suitable for placement of the device as defined in the Instructions For Use (IFU) and as assessed by computed tomography (CT), fluoroscopy or echocardiography.

8. Each patient, or his or her guardian or legal representative, is willing to give informed consent, subject to national law.

Exclusion Criteria:

1. Right ventricular dysfunction
2. Severe AV valve regurgitation of the pulmonary ventricle
3. Complex CHD
4. Ongoing infection
5. Patients where definitive correction of the CHD is indicated and available as a possible treatment option
6. Patients with pressure gradient across the systemic outflow tract/subaortic region >40 mmHg @ rest
7. PAH-CHD patients with small defects that may be incidental findings
8. PAH after corrective cardiac surgery
9. Anatomical limitation to IntelliStent® (e.g. pulmonary artery size)
10. Known or suspected thrombosis of the femoral or iliac veins on the proposed site of venous cannulation
11. Vasculature lesions or characteristics that prevent percutaneous transluminal catheterization
12. Allergies or contraindications to prescribed procedural medications and contrast medium Anomalous pulmonary venous return (total or partial)
13. Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel
14. Mental incapacity, unwillingness or language barrier precluding adequate understanding of the trial procedure or cooperation with trial site personnel
15. Pregnant, lactating or planning pregnancy

The dataset generated during and/or analysed during the study will be available upon request from the Clinical Research Organization, Meditrial USA Inc. m.tocchi@meditrial.net Datasets will only be made available through publication, unless disclosure is mandated by law

Intention to publish date 09/01/2024

Available on request, Published as a supplement to the results publication.