NCT07171060

Laplace Early Feasibility Study - Canada

Laplace Outside the US (OUS) Early Feasibility Study (EFS) Canada

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Laplace Interventional, Inc · Industry
• Sex: All
• Age: 60 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

• Tricuspid Regurgitation

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: 2024-06-18
• Primary completion: 2026-01-01
• Completion: 2031-01-01
• First posted: 2025-09-12
• Last updated: 2025-09-12

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study