Laplace TTVR System for Tricuspid Regurgitation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called the Laplace TTVR System, a type of valve replacement therapy, to determine its safety and effectiveness for individuals with severe tricuspid regurgitation. Tricuspid regurgitation occurs when the heart's tricuspid valve fails to close properly, causing blood to flow backward and potentially leading to symptoms like fatigue and swelling. The trial seeks participants who continue to experience symptoms despite medication and are suitable candidates for this type of valve replacement.
As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, you should discuss your current medications with the trial team to ensure they don't interfere with the study.
What prior data suggests that the Laplace TTVR System is safe for tricuspid regurgitation?
Research has shown that the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System is generally safe. Early studies found that using the Laplace TTVR System in patients with severe tricuspid regurgitation (a condition where the heart's tricuspid valve doesn't close properly) led to noticeable improvements in symptoms and organ function, indicating the treatment is usually well-tolerated.
Another study tested the system in real-life situations and showed positive results without unexpected safety issues. While early results are promising, ongoing studies aim to confirm its safety and effectiveness.
For those interested in joining a trial, note that past studies have shown promising safety data, although the treatment is still under evaluation.12345Why are researchers excited about this trial?
Unlike traditional treatments for tricuspid regurgitation, which often involve open-heart surgery or medications to manage symptoms, the Laplace TTVR System offers a minimally invasive alternative. This system uses a catheter-based approach to replace the tricuspid valve without the need for extensive surgery. Researchers are excited because it potentially reduces recovery time and lowers the risk associated with open-heart procedures. Additionally, the Laplace TTVR System directly addresses the faulty valve, offering a targeted solution for severe cases that are symptomatic.
What evidence suggests that the Laplace TTVR System is effective for tricuspid regurgitation?
Research has shown that transcatheter tricuspid valve replacement (TTVR), administered in this trial using the Laplace TTVR System, could be a promising treatment for severe tricuspid regurgitation. This condition arises when the heart's tricuspid valve fails to close properly, causing blood to leak backward. Early studies suggest that TTVR can improve symptoms in patients unresponsive to other treatments. Specifically, one study found that patients who underwent TTVR experienced better heart function and fewer symptoms shortly after the procedure. However, results can vary, and impaired function of the right side of the heart might affect treatment success. Overall, TTVR offers hope for those facing this challenging heart condition.23678
Are You a Good Fit for This Trial?
This trial is for individuals aged 60-90 with severe tricuspid valve regurgitation, who are symptomatic despite optimal medical therapy. They must be suitable for the Laplace TTVR system and agree to follow-up visits. Exclusions include life expectancy under a year, certain heart and lung conditions, drug use, pregnancy potential without contraception, recent major medical events or procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the Transcatheter Tricuspid Valve Replacement (TTVR) procedure
Follow-up
Participants are monitored for safety and effectiveness after the procedure
What Are the Treatments Tested in This Trial?
Interventions
- Laplace TTVR System
Trial Overview
The study tests the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement System in patients with severe tricuspid regurgitation. It involves replacing the faulty valve using a catheter-based approach rather than open-heart surgery.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Transcatheter Tricuspid Valve Replacement (TTVR) System for the treatment of severe, symptomatic tricuspid regurgitation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Laplace Interventional, Inc
Lead Sponsor
Citations
Transcatheter tricuspid valve replacement and valve-in- ...
An 87-year-old man with chronic obstructive pulmonary disease (COPD) and chronic renal insufficiency presented with New York Heart Association ...
Early Outcomes of Real-World Transcatheter Tricuspid ...
Moderate or severe right ventricular dysfunction was an independent predictor of clinical failure at 1-month follow-up (OR: 3.60; 95% CI: 1.39- ...
Advancements in transcatheter tricuspid valve repair and ...
First-in-human transcatheter pledget-assisted suture tricuspid annuloplasty for severe tricuspid insufficiency. Catheter Cardiovasc Interv ...
Tricuspid valve repair and tricuspid valve replacement
Increased right heart pressure and congestive heart failure are considered risk factors for development of liver fibrosis. Liver fibrosis, if progressive, may ...
Laplace TTVR System for Tricuspid Regurgitation
This trial is for individuals aged 60-90 with severe tricuspid valve regurgitation, who are symptomatic despite optimal medical therapy. They must be suitable ...
Early Feasibility Study (EFS) Laplace Transcatheter ...
About this study. The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve ...
TTVR System for Tricuspid Regurgitation
The meta-analysis of 35 studies involving 5,316 patients found that the operative mortality rate for isolated surgical tricuspid valve replacement (TVR) was 12% ...
TTVR Remains Safe, Effective in Presence of CIED Leads
The rate of death or HF hospitalization was not influenced by the presence of leads after accounting for comorbidity burden.
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