RECRUITING

Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System

Conditions

Pulmonary Arterial Hypertension Pulmonary Hypertension Right Heart Dysfunction Pulmonary Disease Pulmonary Artery Lung Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This prospective study is a multi-center early feasibility study assessing the safety and performance of the Aria CV Pulmonary Hypertension System in patients with pulmonary hypertension and right heart dysfunction.

Official Title

An Early Feasibility Study Assessing Treatment of Pulmonary Hypertension Using the Aria CV Pulmonary Hypertension System

Quick Facts

Study Start:2021-03-15

Study Completion:2026-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04555161

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 18 years of age or older. 2. Mean pulmonary artery pressure (mPAP) \> 25mmHg. 3. Right heart dysfunction as evidence by at least one of the following: 1. Tricuspid Annulus Plan Systolic Excursion (TAPSE) ≤ 16mm 2. RV Fractional area change \< 35% 3. RV systolic velocity \< 11.5 cm/s 4. RV free wall strain \< 18% 5. Lateral tricuspid annulus peak systolic velocity (S') \< 9cm/s 4. Pulmonary compliance (C) \< 3.0 ml/mmHg 5. Current assessment of WHO FC III or ambulatory IV 6. Main pulmonary artery (MPA) diameter and anatomy suitable for placement of the device as defined in the Instructions For Use (IFU) and as assessed by multi-slice computed tomography (MSCT). 7. Subject is deemed appropriate for Aria CV device by the Subject Care Team at the investigation site and approved by the Eligibility Review Committee (ERC). 8. The subject has agreed to participate in the study by signing the study specific informed consent form. 9. The subject agrees to abide by device related travel restrictions. 10. Pulmonary capillary wedge pressure (PCWP) ≤ 15mmHg 11. Pulmonary vascular resistance (PVR) \> 3 Woods Units (WU) 12. The subject remains symptomatic despite being on a stable drug regimen of PH specific medication(s) appropriate for their PH classification for at least 90 days prior to planned index procedure. 10. Previous diagnosis of heart failure with preserved ejection fraction (HFpEF) (ejection fraction ≥ 50%) 11. PCWP \> 15 mmHg 12. PVR \> 3 WU 10. Previous diagnosis of lung disease, including but not limited to chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD) including idiopathic pulmonary fibrosis (IPF) or combined emphysema with fibrosis. 11. PCWP ≤ 15mmHg 12. PVR \>4 WU	1. Diagnosis of WHO Groups 4 or 5 PH. 2. Recent clinical event(s) of any of the following: 1. Myocardial infarction or stroke within 6 months prior to the index procedure; 2. Sustained tachyarrhythmia (documented heart rate \>110/min) within 2 months prior to the index procedure; 3. Uncontrolled, chronic atrial fibrillation. 3. Pre-existing or requirement of emergent surgery/ intervention, or implantation of prosthetic cardiac device that, in the opinion of the investigator, may interfere with Aria CV PH System placement or function. 4. Any of the following medical history or comorbidities: 5. Anatomy is not suitable for placement of Aria CV device. 6. Right heart valve regurgitation as follows: 1. Moderate to severe (Grade 3 or 4) pulmonary valve regurgitation; 2. Severe (Grade 4) tricuspid valve regurgitation. 7. Hypersensitivity or contraindication to: 1. Required medications (e.g., contrast agents, warfarin, heparin) which cannot be adequately managed; 2. Materials in device including polyurethane, silicone, nickel, and titanium. 8. Ineligible for or refuses blood transfusion. 9. Pregnant, nursing or is planning to become pregnant in the next two years. 10. Life expectancy of less than two years. 11. Currently participating in or planning to participate in other investigational study that may interfere with the outcome of this study. 12. For subject on supplemental oxygen therapy - Subject adheres to the treatment regimen that in the opinion of the physician does not increase subject's safety. 13. Previous diagnosis of cardiac amyloidosis. 1. Previous diagnosis of idiopathic hypertrophic subaortic stenosis (IHSS, also known as hypertrophic obstructive cardiomyopathy - HOCM). 2. Untreated severe aortic or mitral stenosis 3. Diagnosis of heart failure with reduced ejection fraction (HFrEF) 4. Previous diagnosis of nonobstructive hypertrophic cardiomyopathy.

Inclusion Criteria

Exclusion Criteria

1. 18 years of age or older.
2. Mean pulmonary artery pressure (mPAP) \> 25mmHg.
3. Right heart dysfunction as evidence by at least one of the following:
1. Tricuspid Annulus Plan Systolic Excursion (TAPSE) ≤ 16mm
2. RV Fractional area change \< 35%
3. RV systolic velocity \< 11.5 cm/s
4. RV free wall strain \< 18%
5. Lateral tricuspid annulus peak systolic velocity (S') \< 9cm/s
4. Pulmonary compliance (C) \< 3.0 ml/mmHg
5. Current assessment of WHO FC III or ambulatory IV
6. Main pulmonary artery (MPA) diameter and anatomy suitable for placement of the device as defined in the Instructions For Use (IFU) and as assessed by multi-slice computed tomography (MSCT).
7. Subject is deemed appropriate for Aria CV device by the Subject Care Team at the investigation site and approved by the Eligibility Review Committee (ERC).
8. The subject has agreed to participate in the study by signing the study specific informed consent form.
9. The subject agrees to abide by device related travel restrictions.
10. Pulmonary capillary wedge pressure (PCWP) ≤ 15mmHg
11. Pulmonary vascular resistance (PVR) \> 3 Woods Units (WU)
12. The subject remains symptomatic despite being on a stable drug regimen of PH specific medication(s) appropriate for their PH classification for at least 90 days prior to planned index procedure.
10. Previous diagnosis of heart failure with preserved ejection fraction (HFpEF) (ejection fraction ≥ 50%) 11. PCWP \> 15 mmHg 12. PVR \> 3 WU
10. Previous diagnosis of lung disease, including but not limited to chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD) including idiopathic pulmonary fibrosis (IPF) or combined emphysema with fibrosis.
11. PCWP ≤ 15mmHg 12. PVR \>4 WU

1. Diagnosis of WHO Groups 4 or 5 PH.
2. Recent clinical event(s) of any of the following:
1. Myocardial infarction or stroke within 6 months prior to the index procedure;
2. Sustained tachyarrhythmia (documented heart rate \>110/min) within 2 months prior to the index procedure;
3. Uncontrolled, chronic atrial fibrillation.
3. Pre-existing or requirement of emergent surgery/ intervention, or implantation of prosthetic cardiac device that, in the opinion of the investigator, may interfere with Aria CV PH System placement or function.
4. Any of the following medical history or comorbidities:
5. Anatomy is not suitable for placement of Aria CV device.
6. Right heart valve regurgitation as follows:
1. Moderate to severe (Grade 3 or 4) pulmonary valve regurgitation;
2. Severe (Grade 4) tricuspid valve regurgitation.
7. Hypersensitivity or contraindication to:
1. Required medications (e.g., contrast agents, warfarin, heparin) which cannot be adequately managed;
2. Materials in device including polyurethane, silicone, nickel, and titanium.
8. Ineligible for or refuses blood transfusion.
9. Pregnant, nursing or is planning to become pregnant in the next two years.
10. Life expectancy of less than two years.
11. Currently participating in or planning to participate in other investigational study that may interfere with the outcome of this study.
12. For subject on supplemental oxygen therapy - Subject adheres to the treatment regimen that in the opinion of the physician does not increase subject's safety.
13. Previous diagnosis of cardiac amyloidosis.
1. Previous diagnosis of idiopathic hypertrophic subaortic stenosis (IHSS, also known as hypertrophic obstructive cardiomyopathy - HOCM).
2. Untreated severe aortic or mitral stenosis
3. Diagnosis of heart failure with reduced ejection fraction (HFrEF)
4. Previous diagnosis of nonobstructive hypertrophic cardiomyopathy.

Contacts and Locations

Study Contact

Caytie Longhenry

CONTACT

651-200-4891

clonghenry@ariacv.com

Sydney Powell

CONTACT

651-200-4891

spowell@ariacv.com

Principal Investigator

Aaron Waxman, M.D.,Ph.D.

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

University of California - San Diego

La Jolla, California, 92093

United States

University of California-Los Angeles

Los Angeles, California, 90095

United States

St. Vincent Health

Indianapolis, Indiana, 46260

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Beaumont Hospital

Royal Oak, Michigan, 48073

United States

University of Minnesota

Minneapolis, Minnesota, 55435

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Cornell University

New York, New York, 10065

United States

University of Rochester

New York, New York, 14627

United States

The Christ Hospital

Cincinnati, Ohio, 45219

United States

The Ohio State University

Columbus, Ohio, 43210

United States

Ohio Health

Columbus, Ohio, 43214

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Aurora St Luke's Medical Center

Milwaukee, Wisconsin, 53215

United States

Collaborators and Investigators

Sponsor: Aria CV, Inc

Aaron Waxman, M.D.,Ph.D., PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-15

Study Completion Date2026-10

Study Record Updates

Study Start Date2021-03-15

Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

Pulmonary Disease
Pulmonary Artery
Pulmonary Hypertension
Lung Disease
Right Heart Dysfunction

Additional Relevant MeSH Terms

Pulmonary Arterial Hypertension
Pulmonary Hypertension
Right Heart Dysfunction