HEARTFUL-CHD: IntelliStent Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy

Sponsor

HeartPoint Global (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06072937

Collaborator

Meditrial USA Inc. (Other)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension Dilated Cardiomyopathy Congenital Heart Disease	Device: IntelliStent	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single Arm Early Feasibility TrialSingle Arm Early Feasibility Trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 4, 2024

Anticipated Primary Completion Date :

Mar 4, 2025

Anticipated Study Completion Date :

Mar 4, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IntelliStent Arm Single Arm Safety and Effectiveness of the IntelliStent System	Device: IntelliStent 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.

Arm

Intervention/Treatment

Experimental: IntelliStent Arm

Single Arm Safety and Effectiveness of the IntelliStent System

Device: IntelliStent

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.

Outcome Measures

Primary Outcome Measures

Change in pulmonary vascular resistance (PVR) [24 Weeks]
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.

Secondary Outcome Measures

Six Minute Walk Test Distance [12 Weeks]
Change from baseline of six minute walk test distance (meters) at Week 12.
Change From Baseline to Week 12 in Borg Dyspnea Score [Baseline to 12 weeks]
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).
NYHA Class change from Baseline at Week 12 [Baseline to 12 weeks]
New York Heart Association Class (NYHA) class: minimum I; maximum IV ( worse)
Change From Baseline to Week 12 in Ejection Fraction [Baseline to 12 Weeks]
Ejection Fraction (%) measured by transthoracic echocardiography
Change From Baseline to Week 12 in Left Ventricular Volumes [Baseline to 12 Weeks]
Left Ventricular Volumes measured by transthoracic echocardiography
Change From Baseline of the Kansas City Cardiomyopathy Questionnaire (KCCQ) [Baseline to 12 Weeks]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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