Aria CV System for Pulmonary Arterial Hypertension

(ASPIRE PH Trial)

Recruiting in Palo Alto (17 mi)

+13 other locations

Overseen by Aaron Waxman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Aria CV, Inc

Must be taking: PH specific medications

Must not be taking: Immunosuppressants, others

Disqualifiers: Renal insufficiency, Scleroderma, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing a new device called the Aria CV PH System, which helps manage high blood pressure in the lungs and supports heart function. It is aimed at patients with pulmonary hypertension and related heart issues. The study will check if the device is safe and effective over a period of several months to a few years.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be on a stable drug regimen for pulmonary hypertension for at least 90 days before the procedure, suggesting you may need to continue your current medications.

How is the Aria CV Pulmonary Hypertension System treatment different from other treatments for pulmonary arterial hypertension?

The Aria CV Pulmonary Hypertension System is unique because it is a device-based treatment, unlike most existing therapies that are primarily medications. This system is designed to mechanically assist the heart in managing blood flow, offering a novel approach compared to traditional drug therapies that focus on altering blood vessel function or pressure. ^{1 2 3 4 5}

Research Team

Aaron Waxman, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

Adults with pulmonary hypertension and right heart dysfunction who still have symptoms despite taking specific medications for at least 90 days. They must not have certain severe heart conditions, recent major cardiovascular events, or other health issues that could interfere with the trial's device.

Inclusion Criteria

I have a lung condition like COPD or fibrosis, but my heart and lung pressures are within specific limits.

I have been diagnosed with heart failure but my heart still pumps well.

Your pulmonary capillary wedge pressure is less than or equal to 15 mmHg for people with a specific type of heart condition.

Exclusion Criteria

I have been diagnosed with a type of heart disease that thickens my heart muscle.

I have been diagnosed with hypertrophic obstructive cardiomyopathy.

I have had a heart attack, stroke, or serious heart rhythm problems recently.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Pre-operative evaluation before the implant procedure

1 week

1 visit (in-person)

Implant Procedure

Implantation of the Aria CV Pulmonary Hypertension System

1 day

1 visit (in-person)

Post-implant Follow-up

Follow-up visits to assess the Aria CV PH System at various intervals

24 months

Multiple visits at 7 days, 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24 months post-implant

Long-term Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Aria CV Pulmonary Hypertension System (Device)

Trial Overview The Aria CV Pulmonary Hypertension System is being tested in this study to see if it's safe and works well for patients with pulmonary hypertension and problems with the right side of their heart.

Participant Groups

Group I: Aria CV Pulmonary Hypertension System Experimental Treatment 1 Intervention

Treatment with the Aria CV Pulmonary Hypertension System

Who Is Running the Clinical Trial?

Aria CV, Inc

Lead Sponsor

Trials

2

Recruited

50+

Founded

2010

Headquarters

St. Paul, USA

Known For

Pulmonary Hypertension

Top Products

Aria CV Pulmonary Hypertension System

Findings from Research

An artificial intelligence algorithm developed using data from over 56,000 ECGs showed high accuracy in predicting pulmonary hypertension (PH), with area under the curve values of 0.859 for internal validation and 0.902 for external validation.

The AI algorithm effectively identified patients at higher risk for developing PH, with a significant difference in risk (31.5% vs 5.9%) during follow-up for those classified as high-risk compared to low-risk, highlighting its potential for early diagnosis and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artificial intelligence for early prediction of pulmonary hypertension using electrocardiography. Kwon, JM., Kim, KH., Medina-Inojosa, J., et al.[2021]

The proposed classification system for pediatric pulmonary hypertension aims to enhance diagnostic strategies and clinical investigations, focusing on factors like perinatal maladaptation and pulmonary hypoplasia as key causes.

This new system categorizes pediatric pulmonary hypertensive vascular disease into 10 broad categories, emphasizing the role of genetic and congenital factors in the disease's presentation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A consensus approach to the classification of pediatric pulmonary hypertensive vascular disease: Report from the PVRI Pediatric Taskforce, Panama 2011. Cerro, MJ., Abman, S., Diaz, G., et al.[2021]

The PAHcare™ digital platform is being evaluated in a study involving 50 patients with pulmonary arterial hypertension (PAH) across six specialized centers, focusing on its impact on health-related quality of life and patient engagement in their treatment.

The platform aims to enhance communication between patients and healthcare providers, improve patient knowledge and empowerment, and streamline the management of PAH, with the study expected to conclude in September 2022.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a digital health system (PAHcare™) for routine care of patients with pulmonary arterial hypertension: The CBS-PAH study protocol. Pérez Peñate, G., Ochoa Parra, N., Domingo Morera, JA., et al.[2023]

A survey of 30 pulmonary vascular disease centers revealed that 93% use PAH-approved therapies for patients with non-group 1 pulmonary hypertension (PH), particularly in groups 2 and 3, indicating a broad application of these treatments beyond their original approval.

The decision to use PAH therapy in patients with non-group 1 PH is primarily based on hemodynamic factors and right ventricular dysfunction, highlighting the need for clinical trials to evaluate the efficacy of these therapies in these specific patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of pulmonary arterial hypertension-approved therapy in the treatment of non-group 1 pulmonary hypertension at US referral centers. Trammell, AW., Pugh, ME., Newman, JH., et al.[2020]

The 2013 clinical guidelines for pulmonary hypertension (PH) developed by Russian experts incorporate the latest classifications, pathogenesis insights, and diagnostic algorithms, enhancing the understanding and management of this serious condition.

Current treatment options for PH include a range of medications such as calcium antagonists, prostanoids, and phosphodiesterase type 5 inhibitors, along with surgical interventions, which together offer promising strategies to improve patient outcomes and prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical guidelines for the diagnosis and treatment of pulmonary hypertension]. Chazova, IE., Avdeev, SN., Tsareva, NA., et al.[2014]

References

1. United States pubmed.ncbi.nlm.nih.gov

Artificial intelligence for early prediction of pulmonary hypertension using electrocardiography. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

A consensus approach to the classification of pediatric pulmonary hypertensive vascular disease: Report from the PVRI Pediatric Taskforce, Panama 2011. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of a digital health system (PAHcare™) for routine care of patients with pulmonary arterial hypertension: The CBS-PAH study protocol. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Use of pulmonary arterial hypertension-approved therapy in the treatment of non-group 1 pulmonary hypertension at US referral centers. [2020]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Clinical guidelines for the diagnosis and treatment of pulmonary hypertension]. [2014]