Clinical trial NCT06072937: IntelliStent for Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy
Official title: Clinical Evaluation of HeartPoint Global Intellistent for Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Dilated Cardiomyopathy
Congenital Heart Disease
Keywords: pediatric cardiology
pulmonary arterial hypertension
dilated cardiomyopathy
Lead sponsor: HeartPoint Global
Sponsor class: INDUSTRY
Collaborators: name: Meditrial USA Inc.
First posted: 2023-10-10
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Arm Early Feasibility Trial
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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).

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

Primary outcomes:
measure: Change in pulmonary vascular resistance (PVR)
timeFrame: 24 Weeks
Secondary outcomes:
measure: Six Minute Walk Test Distance
timeFrame: 12 Weeks
measure: Change From Baseline to Week 12 in Borg Dyspnea Score
timeFrame: Baseline to 12 weeks
measure: NYHA Class change from Baseline at Week 12
timeFrame: Baseline to 12 weeks
measure: Change From Baseline to Week 12 in Ejection Fraction
timeFrame: Baseline to 12 Weeks
measure: Change From Baseline to Week 12 in Left Ventricular Volumes
timeFrame: Baseline to 12 Weeks
measure: Change From Baseline of the Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Baseline to 12 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Meditrial USA Inc. Clinical Research Organization
name: Monica Tocchi, MD, PhD
role: STUDY_DIRECTOR
References: