Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System
NCT04555161 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-09-29
Summary
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
- Pulmonary Arterial Hypertension
- Pulmonary Hypertension
- Right Heart Dysfunction
Interventions
- DEVICE
-
Aria CV Pulmonary Hypertension System
The Aria CV PH System is indicated for the treatment of adult patients diagnosed with Pulmonary Hypertension in World Health Organization (WHO) Groups I, II, and III who remain symptomatic despite treatment with optimal medical therapy.
Sponsors & Collaborators
-
Aria CV, Inc
lead INDUSTRY
Principal Investigators
-
Ashwin Ravichandran, M.D. · Ascension Health
-
Jim White, M.D., Ph.D. · University of Rochester
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-15
- Primary Completion
- 2025-10-31
- Completion
- 2026-10-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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