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Acute Assessment of the Aria CV System in Patients With WHO Groups 2 and 3 Pulmonary Hypertension

NCT05001711 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-03-20

No results posted yet for this study

Summary

This study is a prospective, non-randomized, two arm, single-center acute feasibility study assessing safety and performance of the Aria CV Acute PH System in WHO Group 2 and 3 PH patients.

Conditions

  • Pulmonary Hypertension

Interventions

DEVICE

Aria CV Acute PH System

The Aria CV Acute PH System is indicated for evaluation of hemodynamic responses (e.g. pulmonary arterial compliance, cardiac output, and effective arterial elastance) to an intravascular Balloon catheter temporarily placed in the pulmonary artery in symptomatic adult patients with WHO Group 2 or WHO Group 3 pulmonary hypertension and right ventricular dysfunction.

Sponsors & Collaborators

  • Aria CV, Inc

    lead INDUSTRY

Principal Investigators

  • Irene M Lang, MD · Medical University of Vienna

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-12
Primary Completion
2021-12-30
Completion
2022-01-06

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05001711 on ClinicalTrials.gov