Actively Recruiting
Laplace Early Feasibility Study - Canada
Led by Laplace Interventional, Inc · Updated on 2025-09-12
15
Participants Needed
1
Research Sites
341 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
Laplace Early Feasibility Study - Canada
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 60 and 90 years at the time of the study procedure
- Symptomatic tricuspid regurgitation despite at least 30 days of optimal medical therapy
- Severe, massive, or torrential tricuspid regurgitation confirmed by echocardiogram
- Suitable candidate for transcatheter tricuspid valve replacement as determined by the local heart team and patient selection committee
- Anatomically appropriate for the Laplace TTVR system including trans-jugular access
- 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
- Systolic pulmonary artery pressure greater than 65 mmHg
- Pulmonary vascular resistance greater than 5 Wood units
- Acutely decompensated condition with low blood pressure or recent use of hemodynamic support or inotropes
- Severe COPD requiring home oxygen or chronic oxygen use
- Severe right ventricular dysfunction by echocardiogram
- Severe aortic, mitral, or pulmonic valve stenosis or regurgitation requiring treatment
- New or untreated intracardiac masses, thrombus, or infections in the right heart chambers or superior vena cava
- Significant congenital heart disease affecting the right heart
- Untreatable allergies to certain blood thinners or device materials
- Severe kidney failure with eGFR below 25 mL/min or on dialysis
- History of illicit drug use within last 5 years
- Recent cardiovascular or carotid surgery or interventions within specified time frames
- Planned cardiac surgery within next 12 months
- Recent stroke or major cerebrovascular event within 90 days
- Untreated significant coronary artery disease or recent acute coronary syndrome
- Recent active gastrointestinal bleeding or contraindication to anticoagulation
- Bleeding disorders or abnormal platelet counts
- Transfusion-dependent anemia with low hemoglobin
- Current or planned pregnancy within next 12 months
- Recent or active infections such as endocarditis or sepsis
- Prior tricuspid valve repair, replacement, or device interfering with study device
- Participation in other investigational cardiac device or drug studies
- Other medical or psychological conditions limiting participation or compliance
- Left ventricular ejection fraction less than 30%
- Recent deep vein thrombosis or pulmonary embolism within 6 months
- Severe liver disease (Child-Pugh C)
- Contraindication or inability to complete transesophageal echocardiogram
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
Research Team
R
Ryan Gladney
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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