Actively Recruiting
Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System
Led by Aria CV, Inc · Updated on 2025-09-29
30
Participants Needed
12
Research Sites
289 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Mean pulmonary artery pressure greater than 25 mmHg
- Evidence of right heart dysfunction by at least one measure: TAPSE ≤ 16 mm, RV fractional area change < 35%, RV systolic velocity < 11.5 cm/s, RV free wall strain < 18%, or lateral tricuspid annulus peak systolic velocity (S') < 9 cm/s
- Pulmonary compliance less than 3.0 ml/mmHg
- Current WHO functional classification III or ambulatory IV
- Suitable main pulmonary artery diameter and anatomy for device placement as assessed by multi-slice computed tomography
- Approved as appropriate for Aria CV device by care team and Eligibility Review Committee
- Signed informed consent and agreement to follow device-related travel restrictions
- For WHO Group I: Pulmonary capillary wedge pressure ≤ 15 mmHg and pulmonary vascular resistance > 3 Woods Units, stable PH medication regimen for at least 90 days
- For WHO Group II: Previous diagnosis of heart failure with preserved ejection fraction (ejection fraction ≥ 50%), pulmonary capillary wedge pressure > 15 mmHg, pulmonary vascular resistance > 3 Woods Units
- For WHO Group III: Previous diagnosis of lung disease including COPD, interstitial lung disease, idiopathic pulmonary fibrosis, or combined emphysema with fibrosis, pulmonary capillary wedge pressure ≤ 15 mmHg, pulmonary vascular resistance > 4 Woods Units
You will not qualify if you...
- Diagnosis of WHO Groups 4 or 5 pulmonary hypertension
- Recent myocardial infarction or stroke within 6 months
- Sustained tachyarrhythmia (heart rate >110/min) within 2 months
- Uncontrolled chronic atrial fibrillation
- Need for emergent surgery or prosthetic cardiac device that may interfere with Aria CV placement or function
- History of endocarditis or unprovoked pulmonary embolism
- Renal insufficiency with eGFR < 30 mL/min/1.73 m2 or dialysis
- Scleroderma with recent GI bleeding or significant skin involvement compromising daily activities or IV medication access
- Use of certain immunosuppressants near enrollment
- Pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis
- Significant patent foramen ovale or other cardiac shunts
- History of gastrointestinal or intracranial bleeding increasing bleeding risk
- Active infection requiring antibiotics within 2 weeks
- Blood disorders increasing procedural risks
- Unsuitable anatomy for device placement
- Moderate to severe pulmonary valve regurgitation or severe tricuspid valve regurgitation
- Allergy or contraindication to required medications or device materials
- Ineligible for or refusal of blood transfusion
- Pregnant, nursing, or planning pregnancy in next 2 years
- Life expectancy under 2 years
- Current participation in conflicting investigational studies
- Supplemental oxygen therapy regimen deemed unsafe by physician
- Previous diagnosis of cardiac amyloidosis
- For WHO Group II: Idiopathic hypertrophic subaortic stenosis, untreated severe aortic or mitral stenosis, heart failure with reduced ejection fraction, or nonobstructive hypertrophic cardiomyopathy
AI-Screening
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Trial Site Locations
Total: 12 locations
1
University of California - San Diego
La Jolla, California, United States, 92093
Withdrawn
2
University of California-Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
3
St. Vincent Health
Indianapolis, Indiana, United States, 46260
Actively Recruiting
4
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
5
University of Minnesota
Minneapolis, Minnesota, United States, 55435
Actively Recruiting
6
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
7
Cornell University
New York, New York, United States, 10065
Actively Recruiting
8
University of Rochester
New York, New York, United States, 14627
Actively Recruiting
9
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Withdrawn
10
Ohio Health
Columbus, Ohio, United States, 43214
Actively Recruiting
11
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
12
Aurora St Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Withdrawn
Research Team
C
Caytie Longhenry
CONTACT
V
VP of Clinical
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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