Status:
NOT_YET_RECRUITING
IntelliStent for Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy
Lead Sponsor:
HeartPoint Global
Collaborating Sponsors:
Meditrial USA Inc.
Conditions:
Pulmonary Arterial Hypertension
Dilated Cardiomyopathy
Eligibility:
All Genders
12-60 years
Phase:
NA
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 associat...
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 (P...
Eligibility Criteria
Inclusion
- 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)
- ≤ 15 mmHg.
- 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.
- 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.
- Each patient, or his or her guardian or legal representative, is willing to give informed consent, subject to national law.
Exclusion
- 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
- Patients with pressure gradient across the systemic outflow tract/subaortic region \>40 mmHg @ rest
- PAH-CHD patients with small defects that may be incidental findings
- PAH after corrective cardiac surgery
- Anatomical limitation to IntelliStent® (e.g. pulmonary artery size)
- Known or suspected thrombosis of the femoral or iliac veins on the proposed site of venous cannulation
- Vasculature lesions or characteristics that prevent percutaneous transluminal catheterization
- Allergies or contraindications to prescribed procedural medications and contrast medium Anomalous pulmonary venous return (total or partial)
- 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
Key Trial Info
Start Date :
June 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 4 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06072937
Start Date
June 4 2024
End Date
June 4 2026
Last Update
May 16 2024
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