Aria CV System for Pulmonary Arterial Hypertension

(ASPIRE PH Trial)

Recruiting at 10 trial locations

Overseen By Thura Harfi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aria CV, Inc

Must be taking: PH specific medications

Must not be taking: Immunosuppressants, others

Disqualifiers: Renal insufficiency, Scleroderma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Aria CV Pulmonary Hypertension System, designed to help people with pulmonary arterial hypertension (a type of high blood pressure affecting the lungs) and right heart dysfunction. The trial aims to determine the device's safety and effectiveness. Individuals with persistent symptoms despite being on medication for at least 90 days might be suitable candidates. Participants should have a history of lung disease or heart problems that impact daily life. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance future treatments for pulmonary hypertension.

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.

What prior data suggests that the Aria CV Pulmonary Hypertension System is safe for patients with pulmonary hypertension?

Research has shown that the Aria CV Pulmonary Hypertension System has been tested for safety and effectiveness in individuals with pulmonary hypertension, a condition characterized by high blood pressure in the lungs. One study examined the system's safety and found it practical, with reports indicating that patients generally tolerated it well. No serious side effects were directly linked to the device during this study.

The Aria CV device is fully implanted, eliminating the need for external power or connections. This design enhances convenience and reduces risk for patients. Although the trial phase is "Not Applicable," indicating limited safety data, current evidence suggests the device is safe for those considering participation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Aria CV Pulmonary Hypertension System is unique because it uses a mechanical approach to manage pulmonary arterial hypertension (PAH), unlike most current treatments that rely on medications to target blood vessels. Researchers are excited about this system because it acts like a balloon pump to help the heart and lungs work together more effectively, potentially improving blood flow and reducing the heart's workload. This novel approach could offer a new way to alleviate symptoms and improve quality of life for patients with PAH, providing an alternative to traditional drug therapies.

What evidence suggests that the Aria CV Pulmonary Hypertension System is effective for pulmonary hypertension?

Research has shown that the Aria CV Pulmonary Hypertension System, which participants in this trial will receive, can help people with pulmonary hypertension by reducing heart strain and improving blood flow. Early results suggest that this internally placed device might be safe and effective. It operates without an external power source, allowing for long-term use. Studies have found that the device can enhance pulmonary artery function, potentially aiding in symptom management for pulmonary hypertension. Although still under investigation, these early findings offer promise for those seeking new treatment options. ^{1 2 3 4 5}

Who Is on the Research Team?

Ashwin Ravichandran, M.D.

Principal Investigator

Ascension Health

Jim White, M.D., Ph.D.

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Aria CV Pulmonary Hypertension System

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.

How Is the Trial Designed?

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

Treatment with the Aria CV Pulmonary Hypertension System

Aria CV Pulmonary Hypertension System is already approved in United States for the following indications:

Approved in United States as Aria CV PH System for:

• Pulmonary Arterial Hypertension
• Right Heart Dysfunction

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

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04555161

Treatment of Pulmonary Arterial Hypertension Using the ... The purpose of this study is to validate that the clinical use of the Aria CV PH System is safe for the patient and to evaluate its performance in treating ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ejhf.3187

Efficacy and safety of the Aria pulmonary endovascular ... In this acute study, we evaluated feasibility, safety and haemodynamic performance of the Aria pulmonary endovascular device in patients with PH associated ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12307243/

Development of a Novel, Pulmonary Endovascular Device ... The Aria CV device is a totally implanted, long‐term, PH system that requires no external connection or power source. The device consists of a ...

4. respiratory-therapy.com respiratory-therapy.com/disorders-diseases/cardiopulmonary-thoracic/pulmonary-hypertension/aria-cv-implants-first-patient-with-pulmonary-hypertension-system/

Aria CV Implants First Patient with Pulmonary ... Aria's device is designed to restore the benefits of a healthy pulmonary artery by reducing cardiac workload and enhancing blood flow through ...

5. ariacv.com ariacv.com/

Aria CV | A Novel Device To Treat Pulmonary Hypertension Learn about Aria CV's novel implantable medical device designed to treat pulmonary hypertension (PH). Our elegant device has no battery, pump, ...