Actively Recruiting
Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
Led by Laplace Interventional, Inc · Updated on 2025-06-17
45
Participants Needed
6
Research Sites
353 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
CONDITIONS
Official Title
Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 22 and 90 years at the time of the procedure
- Symptomatic tricuspid regurgitation despite optimal medical therapy for at least 30 days
- Severe, massive, or torrential tricuspid regurgitation confirmed by transthoracic or transesophageal echocardiogram
- Suitable candidate for transcatheter tricuspid valve replacement as determined by local heart team and patient selection committee
- Provided informed consent and agrees to attend all post-procedure follow-up visits
You will not qualify if you...
- Estimated life expectancy less than 12 months
- Pulmonary vascular resistance greater than 5 Wood units
- Severe right ventricular dysfunction seen on echocardiogram
- Severe valve stenosis or regurgitation in aortic, mitral, or pulmonic valves requiring treatment
- Significant congenital heart disease such as atrial septal defect, right ventricular dysplasia, or arrhythmogenic right ventricle
- Cardiovascular or carotid surgery or percutaneous intervention within 30 days prior
- Implant or revision of rhythm management device or defibrillator within 90 days prior
- Stroke or major cerebrovascular event within 90 days prior
- Untreated coronary artery disease requiring revascularization or recent acute coronary syndrome or myocardial infarction within 30 days
- Bleeding disorders including low or high platelet counts
- Current or planned pregnancy within 12 months for women of childbearing potential
- Active or recent endocarditis or systemic infection requiring antibiotics within the last 90 or 30 days respectively
- Other medical, social, or psychological conditions limiting study participation or follow-up
- Left ventricular ejection fraction less than 30%
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Tucson Medical Center
Tucson, Arizona, United States, 85712
Actively Recruiting
2
Kaiser Permanente
San Francisco, California, United States, 94118
Actively Recruiting
3
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Actively Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
Providence Heart Institute
Portland, Oregon, United States, 97225
Actively Recruiting
6
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
Research Team
J
Julie Messer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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