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
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System in patients with severe, symptomatic tricuspid regurgitation. This early feasibility, prospective, single-arm, multi-center study aims to evaluate how well this device works in replacing the native tricuspid valve in adults who continue to have symptoms despite optimal medical therapy. Participants receive the Laplace TTVR System, which is a device used for transcatheter replacement of the native tricuspid valve. This procedure is designed to treat severe, massive, or torrential tricuspid regurgitation. The study does not include a comparison group and focuses on assessing technical and procedural success during and after the valve replacement. Throughout the study, participants will undergo assessments to measure technical success during the procedure, procedural success at the time of the procedure, and device success at 30 days after the procedure. Participants are required to provide informed consent and attend all follow-up visits to monitor outcomes and safety. The study includes adults aged 22 to 90 years and excludes those with certain heart conditions or other medical issues that may interfere with participation. The total participation duration varies depending on follow-up needs.
CONDITIONS
Brief 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 study procedure
- Symptomatic tricuspid regurgitation despite optimal medical therapy for at least 30 days prior to consent
- Severe, massive, or torrential tricuspid regurgitation confirmed by qualifying echocardiogram
- Suitable candidate for transcatheter tricuspid valve replacement as determined by local heart team and patient selection committee
- Subject or legally authorized representative provides informed consent and agrees to attend all 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 shown by echocardiogram
- Severe valve stenosis or regurgitation (aortic, mitral, pulmonic) requiring treatment
- Significant congenital heart disease such as atrial septal defect, right ventricular dysplasia, or arrhythmogenic right ventricle
- Cardiovascular interventions or surgeries within last 30 days; certain device implants or revisions within last 90 days
- Stroke or major cerebrovascular event within 90 days before procedure
- Untreated significant coronary artery disease or recent acute coronary syndrome or myocardial infarction
- Bleeding disorders with platelet counts below 70,000 or above 700,000 per mm3
- Current or planned pregnancy within next 12 months for women of childbearing potential
- Active or recent endocarditis, sepsis, or systemic infection requiring antibiotics within last 30 days
- Other medical, social, or psychological conditions limiting participation or compliance
- Left ventricular ejection fraction less than 30%
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Procedure day
Participants receive the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System as a transcatheter replacement of the native tricuspid valve.
1 procedure visit (in-person)
Duration - 30 days post-procedure
Participants are monitored for device success and procedural outcomes after the valve replacement procedure.
Approximately 3 follow-up visits (in-person)
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
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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