Force Feedback Instruments for Heart Valve Leak
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new tools that help doctors repair heart valves more precisely during surgery. It focuses on individuals with mitral regurgitation, a condition where a heart valve doesn't close properly, causing blood to leak backward. The trial evaluates whether these tools, known as Force Feedback Instruments, are safe and effective when used with the da Vinci Surgical System Model IS5000, a robotic surgery system. Candidates for this trial have moderate to severe mitral regurgitation confirmed by a doctor and qualify for robotic heart surgery. As an unphased trial, it offers patients the chance to contribute to innovative surgical advancements that could enhance heart valve repair techniques.
Do I need to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that these force feedback instruments are safe for mitral valve repair?
Research has shown that robotic mitral valve repair is generally safe and effective. Patients undergoing these procedures often experience less blood loss, pain, and risk of infection. The FDA-approved da Vinci Surgical System enhances this process by using advanced technology to improve patient safety and outcomes.
While researchers continue to study the Force Feedback instruments used with this system, the da Vinci platform itself has a strong safety record. It collects over 1,000 data points every second to ensure accuracy, making the instruments promising for those considering trial participation. However, as with any medical procedure, discussing potential risks with a healthcare provider is important.12345Why are researchers excited about this trial?
Researchers are excited about the use of force feedback instruments with the da Vinci Surgical System for mitral valve repair because it offers a new level of precision and control in robotic-assisted surgeries. This advanced technology allows surgeons to receive tactile feedback, which is not available in most traditional robotic systems, potentially improving the accuracy of valve repairs. This innovation could lead to better outcomes for patients with mitral regurgitation by enhancing the surgeon's ability to perform delicate procedures more effectively.
What evidence suggests that Force Feedback Instruments are effective for heart valve leak?
Studies have shown that robotic mitral valve repair is effective and safe. In this trial, participants will undergo mitral valve repair using the da Vinci Surgical System with force feedback instruments. Patients using the da Vinci Surgical System often lose less blood, experience less pain after surgery, recover faster, and face a lower risk of infection. The system's special instruments enhance surgical precision. Although specific data on these instruments is limited, the overall robotic system has received approval for heart surgeries, making it a promising option for mitral valve repair.12345
Are You a Good Fit for This Trial?
This trial is for adults age 22 or older with moderate to severe mitral valve leakage (mitral regurgitation) due to a degenerative cause, who have good heart function and are suitable for minimally invasive robotic surgery. Participants must be able to give consent and attend follow-up visits.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo robotic-assisted mitral valve repair using Force Feedback instruments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Force Feedback Instruments with da Vinci Surgical System Model IS5000
Trial Overview
The study tests the safety and effectiveness of using new Force Feedback instruments during robotic-assisted mitral valve repair with the da Vinci Surgical System (Model IS5000).
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients with moderate-severe or severe mitral regurgitation resulting from primary (degenerative) etiology who are candidates for robotic-assisted mitral valve repair.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Intuitive Surgical
Lead Sponsor
Gary Guthart
Intuitive Surgical
Chief Executive Officer since 2010
PhD in Engineering, California Institute of Technology
Henry Charlton
Intuitive Surgical
Chief Medical Officer since 2023
MD from an unspecified institution
Citations
Use of Force Feedback Instruments With the da Vinci ...
This study aims to test the safety and effectiveness of Force Feedback instruments used during robotic-assisted mitral valve repair with the da ...
2.
isrg.intuitive.com
isrg.intuitive.com/news-releases/news-release-details/da-vinci-5-cleared-cardiac-proceduresDa Vinci 5 Cleared for Cardiac Procedures
Smart instrumentation capturing 1,000+ data points per second. using non-force feedback instruments: Mitral valve repair
Robotic mitral valve surgery: overview, methodology, results ...
They show that robotic mitral valve repair is safe and effective, as well as economically reasonable due to lower costs of hospitalization.
4.
trial.medpath.com
trial.medpath.com/clinical-trial/8ea95bd9dbba58cf/nct07655505-force-feedback-da-vinci-mitral-valve-repairUse of Force Feedback Instruments With the... | Clinical Trial
This study aims to test the safety and effectiveness of Force Feedback instruments used during robotic-assisted mitral valve repair with the da ...
Use of Force Feedback Instruments With the da Vinci Surgical ...
This study aims to test the safety and effectiveness of Force Feedback instruments used during robotic-assisted mitral valve repair with the da Vinci Surgical ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.