Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
Laplace Interventional, Inc
Summary
The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
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.
Eligibility
- Age range
- 22–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 22 - 90 years of age at the time of the study procedure 2. Symptomatic tricuspid regurgitation despite being adequately treated with optimal medical therapy by the Local Heart Team for at least 30 days prior to the time of study consent. 3. Severe, massive or torrential tricuspid regurgitation determined by qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE) using the 5-grade classification. 4. Candidate felt suitable for transcatheter tricuspid valve replacement as determined by the local heart team and confirmed by the patient sel…
Interventions
- DeviceLaplace TTVR System
Transcatheter Tricuspid Valve Replacement (TTVR) System for the treatment of severe, symptomatic tricuspid regurgitation
Locations (6)
- Tucson Medical CenterTucson, Arizona
- Kaiser PermanenteSan Francisco, California
- Piedmont HospitalAtlanta, Georgia
- Mayo ClinicRochester, Minnesota
- Providence Heart InstitutePortland, Oregon
- Vanderbilt University Medical CenterNashville, Tennessee