Acute Assessment of the Aria CV System in Patients With WHO Groups 2 and 3 Pulmonary Hypertension
- Conditions
- Pulmonary Hypertension
- Interventions
- Device: Aria CV Acute PH System
- Registration Number
- NCT05001711
- Lead Sponsor
- Aria CV, Inc
- Brief 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.
- Detailed Description
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.
The planned enrollment is a maximum enrollment of 40 patients to ensure up to 10 "Device Deployed" subjects in each arm at one site.
The duration of study participation for each subject is expected to be approximately 60 days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description WHO Group 2 Aria CV Acute PH System - WHO Group 3 Aria CV Acute PH System -
- Primary Outcome Measures
Name Time Method Primary Safety Endpoint 30 Days Incidence of investigational device-related serious adverse events (SAEs) through 30 days post-index procedure, based on Clinical Events Committee assessment.
- Secondary Outcome Measures
Name Time Method Secondary Safety Endpoint 30 Days All reported adverse events occurring during the study will be summarized by the CEC for seriousness and relatedness based on site-reported data.
Trial Locations
- Locations (1)
Medical University of Vienna
🇦🇹Vienna, Austria