Trials / Recruiting
RecruitingNCT06183684
Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- Laplace Interventional, Inc · Industry
- Sex
- All
- Age
- 22 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
Detailed description
Early Feasibility (EFS), prospective, single-arm, multi-center study to evaluate safety and technical feasibility of the Laplace TTVR System in the treatment of severe, symptomatic tricuspid regurgitation patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Laplace TTVR System | Transcatheter Tricuspid Valve Replacement (TTVR) System for the treatment of severe, symptomatic tricuspid regurgitation |
Timeline
- Start date
- 2024-02-19
- Primary completion
- 2025-12-01
- Completion
- 2030-12-01
- First posted
- 2023-12-27
- Last updated
- 2025-06-17
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06183684. Inclusion in this directory is not an endorsement.