Trials / Active Not Recruiting
Active Not RecruitingNCT03616028
The CONFORMAL Early Feasibility Study
The CONFORMAL Early Feasibility Study An Evaluation of the Safety and Performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- Conformal Medical, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
An evaluation of the safety and performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion
Detailed description
The Conformal Left Atrial Appendage Seal (CLAAS) Device is a permanent implant designed to occlude the left atrial appendage (LAA) to eliminate blood flow into and clot passage from the LAA.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | left atrial appendage closure | Closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the CLAAS device will be performed according to device specific instructions for use based on both TEE guidance, ICE and angiography, femoral access and inter-atrial septum crossing |
Timeline
- Start date
- 2019-02-22
- Primary completion
- 2022-05-27
- Completion
- 2028-06-01
- First posted
- 2018-08-06
- Last updated
- 2026-02-13
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03616028. Inclusion in this directory is not an endorsement.