Trials / Unknown
UnknownNCT05403372
Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- InterShunt Technologies, Inc. · Industry
- Sex
- All
- Age
- 40 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, single arm feasibility study to establish safety and performance of the PAS-C System in subjects with heart failure and elevated left atrial pressure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PAS-C System | The InterShunt PAS-C System is a transcatheter system that creates a shunt by excising tissue from the interatrial septum resulting in a left to right atrial shunt that off-loads elevated left atrial pressure, potentially reducing symptoms and improving quality of life. The PAS-C System does not require a permanent implant to maintain patency of the interatrial shunt. |
Timeline
- Start date
- 2022-05-07
- Primary completion
- 2022-08-06
- Completion
- 2023-08-01
- First posted
- 2022-06-03
- Last updated
- 2023-03-01
Locations
1 site across 1 country: Georgia
Source: ClinicalTrials.gov record NCT05403372. Inclusion in this directory is not an endorsement.