Acute Feasibility Study Assessing Safety and Performance of Aria CV Acute PH System in Patients With WHO Group 2 and 3 Pulmonary Hypertension
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pulmonary Hypertension
- Sponsor
- Aria CV, Inc
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Primary Safety Endpoint
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Primary Safety Endpoint
Time Frame: 30 Days
Incidence of investigational device-related serious adverse events (SAEs) through 30 days post-index procedure, based on Clinical Events Committee assessment.
Secondary Outcomes
- Secondary Safety Endpoint(30 Days)