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

Not Applicable

Not yet recruiting

• Conditions: Pulmonary Arterial Hypertension; Dilated Cardiomyopathy; Congenital Heart Disease
• Interventions: Device: IntelliStent

• Registration Number: NCT06072937
• Lead Sponsor: HeartPoint Global

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).

Study Timeline

• Study First Submitted: 2023-10-03
• Study First Submitted QC: 2023-10-06
• Study First Posted: 2023-10-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16
• Study Start: 2024-06-04
• Primary Completion: 2025-06-04
• Study Completion: 2026-06-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IntelliStent Arm	IntelliStent	Single Arm Safety and Effectiveness of the IntelliStent System

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change From Baseline to Week 12 in Left Ventricular Volumes	Baseline to 12 Weeks	Left Ventricular Volumes measured by transthoracic echocardiography
Six Minute Walk Test Distance	12 Weeks	Change from baseline of six minute walk test distance (meters) at Week 12.
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
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 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).
Change From Baseline to Week 12 in Ejection Fraction	Baseline to 12 Weeks	Ejection Fraction (%) measured by transthoracic echocardiography