Pulmonary Arterial HypertensionHEARTFUL-CHDNCT06072937
IntelliStent for Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy
A study testing IntelliStent in people with Pulmonary Arterial Hypertension and Dilated Cardiomyopathy, run by HeartPoint Global.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Pulmonary Arterial Hypertension, Dilated Cardiomyopathy, Congenital Heart Disease
- What is being tested?
- IntelliStent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 4 Jun 2024to 4 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Evaluation of HeartPoint Global Intellistent for Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy
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.
Read the 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).
- Being tested
- IntelliStent
- Keywords
- pediatric cardiology, pulmonary arterial hypertension, dilated cardiomyopathy
- Medical subject headings
- Pulmonary Arterial Hypertension, Cardiomyopathy, Dilated, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntelliStentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| IntelliStent Arm | Experimental | Single Arm Safety and Effectiveness of the IntelliStent System Receives: Device: IntelliStent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 Weeks
Secondary outcomes (6)
Six Minute Walk Test Distance
Change from baseline of six minute walk test distance (meters) at Week 12.
Measured: 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).
Measured: Baseline to 12 weeks
NYHA Class change from Baseline at Week 12
New York Heart Association Class (NYHA) class: minimum I; maximum IV ( worse)
Measured: Baseline to 12 weeks
Change From Baseline to Week 12 in Ejection Fraction
Ejection Fraction (%) measured by transthoracic echocardiography
Measured: Baseline to 12 Weeks
Change From Baseline to Week 12 in Left Ventricular Volumes
Left Ventricular Volumes measured by transthoracic echocardiography
Measured: 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
Measured: Baseline to 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start4 Jun 2024 (estimated)
- Primary completion4 Jun 2025 (estimated)
- Study completion4 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Arm Early Feasibility Trial
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HeartPoint Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meditrial USA Inc.
- Responsible party
- Sponsor
- Investigators
- Monica Tocchi, MD, PhD, Study director, Meditrial USA Inc. Clinical Research Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072937
- Sponsor's protocol ID
- HPG-001-23
- Acronym
- HEARTFUL-CHD
- Status last verified
- May 2024
- First submitted
- 3 Oct 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset generated during and/or analysed during the study will be available upon request from the Clinical Research Organization, Meditrial USA Inc. m.tocchi@meditrial.net Datasets will only be made available through publication, unless disclosure is mandated by law
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of HeartPoint Global Intellistent for Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06072937
- Acronym / sponsor ID
- HEARTFUL-CHD / HPG-001-23
- Keywords
- pediatric cardiology, pulmonary arterial hypertension, dilated cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- HeartPoint GlobalIndustry (pharma, biotech, devices)
- Collaborators
- Meditrial USA Inc.
- Study start
- 4 Jun 2024 (estimated)
- Primary completion
- 4 Jun 2025 (estimated)
- Study completion
- 4 Jun 2026 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Arm Early Feasibility Trial
| Arm | Type | Receives |
|---|---|---|
| IntelliStent Arm | Experimental | Device: IntelliStentSingle Arm Safety and Effectiveness of the IntelliStent System |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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:
- ≤ 15 mmHg.
- Patients with left ventricular dilated cardiomyopathy with symptoms despite optimal medical therapy
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IntelliStentStaged 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. | Device | IntelliStent Arm |
Primary outcome
Change in pulmonary vascular resistance (PVR)
Time frame: 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.
6 secondary outcomes
Six Minute Walk Test Distance
Time frame: 12 Weeks
Change From Baseline to Week 12 in Borg Dyspnea Score
Time frame: Baseline to 12 weeks
NYHA Class change from Baseline at Week 12
Time frame: Baseline to 12 weeks
Change From Baseline to Week 12 in Ejection Fraction
Time frame: Baseline to 12 Weeks
Change From Baseline to Week 12 in Left Ventricular Volumes
Time frame: Baseline to 12 Weeks
Change From Baseline of the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Baseline to 12 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Heartpoint GlobalLink provided by the sponsor.
- Meditrial Clinical Research OrganizationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The dataset generated during and/or analysed during the study will be available upon request from the Clinical Research Organization, Meditrial USA Inc. m.tocchi@meditrial.net Datasets will only be made available through publication, unless disclosure is mandated by law
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica Tocchi, MD, PhD study director
Meditrial USA Inc. Clinical Research Organization
Questions about this trial
What is this clinical trial studying?
A study testing IntelliStent in people with Pulmonary Arterial Hypertension and Dilated Cardiomyopathy, run by HeartPoint Global.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monica Tocchi, MD, PhD (+1 646 933 1025, m.tocchi@meditrial.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pulmonary vascular resistance (PVR) (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.