Tricuspid Valve Replacement for Tricuspid Regurgitation
(TRICURE EFS Trial)
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the idea that Tricuspid Valve Replacement for Tricuspid Regurgitation is an effective treatment?
The available research shows that Tricuspid Valve Replacement (TTVR) is a promising treatment for severe tricuspid regurgitation, especially in high-risk patients. It is considered safer than traditional surgery, which has high risks. TTVR is expected to improve survival rates and effectively address the heart valve issues caused by tricuspid regurgitation. While still in early development, TTVR is seen as a significant advancement compared to other treatments.12345
What data supports the effectiveness of the treatment Transcatheter Tricuspid Valve Replacement for Tricuspid Regurgitation?
Research shows that Transcatheter Tricuspid Valve Replacement (TTVR) is a promising treatment for severe tricuspid regurgitation, especially in high-risk patients who cannot undergo surgery. Early studies suggest that TTVR can significantly improve survival and address the heart valve issues effectively.12345
What safety data exists for Tricuspid Valve Replacement for Tricuspid Regurgitation?
The provided research does not contain any safety data specific to Tricuspid Valve Replacement for Tricuspid Regurgitation or its related terms such as Transcatheter Tricuspid Valve Replacement or TTVR. The studies focus on mitral valve procedures and COVID-19 vaccine safety, which are unrelated to the tricuspid valve treatment in question.678910
Is Transcatheter Tricuspid Valve Replacement a promising treatment for tricuspid regurgitation?
Yes, Transcatheter Tricuspid Valve Replacement (TTVR) is a promising treatment for tricuspid regurgitation. It is emerging as a new option for patients, especially those who are at high risk for traditional surgery. TTVR is seen as a safer and effective alternative to open-heart surgery, and it may help improve heart and liver function in patients with this condition.1231112
How is the treatment Transcatheter Tricuspid Valve Replacement (TTVR) different from other treatments for tricuspid regurgitation?
Transcatheter Tricuspid Valve Replacement (TTVR) is unique because it offers a less invasive alternative to open-heart surgery for treating tricuspid regurgitation, which is a condition with limited effective medical treatments and high surgical risks. Unlike traditional surgical methods, TTVR is performed through a catheter, reducing recovery time and potentially lowering the risk of complications.1231112
What is the purpose of this trial?
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
Research Team
Susheel Kodali, MD
Principal Investigator
Columbia University Medical Center/ NewYork Presbyterian Hospital
Gorav Ailawadi
Principal Investigator
University of Michigan Hospital and Health Systems
Eligibility Criteria
This trial is for adults with severe tricuspid valve regurgitation, who are considered at high risk for surgery by a heart team. It's not suitable for those with anatomy that doesn't fit the device, involved in another study without reaching its main goal yet, needing urgent intervention or unstable.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Transcatheter Tricuspid Valve Replacement
Transcatheter Tricuspid Valve Replacement is already approved in United States, European Union for the following indications:
- Severe tricuspid regurgitation
- Symptomatic tricuspid valve disease
- Severe tricuspid regurgitation
- Symptomatic tricuspid valve disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
TRiCares
Lead Sponsor