Trials / Completed
CompletedNCT04585308
transShield Embolic Protection System Feasibility Study
Prospective, Multi-center, Single-Arm Feasibility Study of the transShield Embolic Protection System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- TransAortic Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the safety and performance of the transShield Embolic Protection System (EPS) used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
Detailed description
This is a prospective, multi-center, single arm feasibility study to assess the safety and performance of the transShield EPS. Patients with severe native aortic valve stenosis scheduled for TAVR will be screened for study eligibility. Subjects who meet the commercially approved indications for TAVR and comply with the study inclusion/exclusion criteria are eligible for enrollment. Patients will be followed for 30 days post procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | transShield Embolic Protection System | Used for embolic protection during TAVR. |
Timeline
- Start date
- 2020-12-15
- Primary completion
- 2023-03-13
- Completion
- 2023-03-13
- First posted
- 2020-10-14
- Last updated
- 2023-11-22
Locations
4 sites across 2 countries: New Zealand, Venezuela
Source: ClinicalTrials.gov record NCT04585308. Inclusion in this directory is not an endorsement.