IntelliStent Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy

Study Overview
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Brief Summary
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IntelliStent is intended to achieve reduction of pulmonary hypertension, improvements in symptoms and quality of life in adolescent and adult patients with congenital heart disease and dilated cardiomyopathy.

Detailed Description
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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).

Official Title
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Clinical Evaluation of HeartPoint Global Intellistent for Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy

Conditions
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Pulmonary Arterial Hypertension, Dilated Cardiomyopathy, Congenital Heart Disease

Intervention / Treatment
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* Device: IntelliStent


Participation Criteria
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Eligibility Criteria
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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 Eisenmenger or Pre-Eisenmenger syndrome, 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) ≤ 15 mmHg. Pulmonary vascular resistance > 3 Wood Units Reactive pulmonary vascular bed, defined as a reduction in mean PAP by 10 mmHg to < 40 mmHg (Sitbon Criteria) or as a decrease of mPAP or the mPAP/mean systemic arterial pressure (mSAP) ratio by ≥ 20% (Borst Criteria) using inhaled nitric oxide. (Seemingly) fixed pulmonary vascular resistance, not modifiable with oxygen, NO or other medications. Patients with the following anatomical dimensions (gated CT with angio or MRI with EKG) at target implantation site: MPA diameter @ systolic ≥ 15 mm and ≤ 24 mm and length @ systolic ≥ 28 mm, or Left and Right PA Branch diameter @ systolic ≥ 15 mm and ≤ 24 mm and length @ systolic ≥ 28 mm 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. Current WHO Functional Class III or IV. Each patient, or his or her guardian or legal representative, is willing to give informed consent, subject to national law. Exclusion Criteria: Complex CHD Anomalous pulmonary venous return (total or partial) Aortic atresia Heterotaxy syndrome Ongoing infection Anatomical limitation to IntelliStent® (e.g., femoral vein impeded access, pulmonary artery size...) Patients where definitive correction of the CHD is indicated and available as a possible treatment option and who have an acceptable risk of surgery Patients with single ventricle defects Patients with truncus arteriosus Patients with pressure gradient across the systemic outflow tract/subaortic region >40 mmHg @ rest PAH-CHD patients with small defects (ASD <2 cm) PAH after corrective cardiac surgery Severe AV valve regurgitation of the pulmonary ventricle (or of the systemic AV valve in single ventricle patients) Known or suspected thrombosis of the femoral or iliac veins on the proposed site of venous cannulation Allergies or contraindications to prescribed procedural medications and contrast medium Vasculature lesions or characteristics that prevent percutaneous transluminal catheterization Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel Mental incapacity, unwillingness or language barrier precluding adequate understanding of the trial procedure or cooperation with trial site personnel Pregnant, lactating or planning pregnancy

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Arm Early Feasibility Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IntelliStent Arm<br>Single Arm Safety and Effectiveness of the IntelliStent System | Device: IntelliStent<br>* Staged implantation of IntelliStent. The system comprises a nitinol self-expanding stent with a hollow element delivered over-the-wire into the main pulmonary artery or its left and right branches, using an 18 Fr transfemoral introducer sheath. The stent consists of two sections, one with a larger diameter and one with a smaller diameter, available in 6 sizes suitable for vessel sizes ranging from 20mm to 30 mm. Additional smaller sizes are currently under development.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pulmonary vascular resistance (PVR) | The primary efficacy endpoint is a binary variable. For patients with a baseline pulmonary vascular resistance (PVR) >1000 dynes·s·cm-5, success is defined by an absolute reduction in PVR of ≥300 dynes·s·cm-5 at 24 weeks. For patients with a baseline PVR ≤1000 dynes·s·cm-5, success is a 30% reduction in PVR at 24 weeks. | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six Minute Walk Test Distance | Change from baseline of six minute walk test distance (meters) at Week 12. | 12 Weeks | 
| Change From Baseline to Week 12 in Borg Dyspnea Score | The Borg Dyspnea score is a self-rating scale to evaluate the severity of dyspnea (from 0 no shortness of breath at all to 10 very, very severe / maximal shortness of breath). | Baseline to 12 weeks | 
| NYHA Class change from Baseline at Week 12 | New York Heart Association Class (NYHA) class: minimum I; maximum IV ( worse) | Baseline to 12 weeks | 
| Change From Baseline to Week 12 in Ejection Fraction | Ejection Fraction (%) measured by transthoracic echocardiography | Baseline to 12 Weeks | 
| Change From Baseline to Week 12 in Left Ventricular Volumes | Left Ventricular Volumes measured by transthoracic echocardiography | Baseline to 12 Weeks | 
| Change From Baseline of the Kansas City Cardiomyopathy Questionnaire (KCCQ) | KCCQ scores for quality of life are scaled from 0 to 100 and summarized in 25-point ranges: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent | Baseline to 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dilated cardiomyopathy, pediatric cardiology, pulmonary arterial hypertension