IntelliStent for Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy

Launched by HEARTPOINT GLOBAL · Oct 6, 2023

Keywords

ClinConnect Summary

The clinical trial titled "IntelliStent for Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy" is studying a device called IntelliStent. This device aims to help patients with certain heart conditions, such as pulmonary arterial hypertension (high blood pressure in the lungs) and dilated cardiomyopathy (a condition that affects the heart's ability to pump blood). The goal of the trial is to see if the IntelliStent can reduce symptoms of these conditions and improve the quality of life for both children and adults who have congenital heart disease.

To be eligible for this trial, participants should be between the ages of 12 and 75, have specific heart conditions that meet the study criteria, and experience symptoms despite receiving standard medical treatment. Importantly, potential participants must be willing to provide consent for the study. Those who join the trial will undergo tests to see if the IntelliStent can be safely placed in their heart and will be monitored for any improvements in their health. This is an exciting opportunity for patients looking for new ways to manage their heart conditions.

Gender

ALL

Eligibility criteria

• 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