Status not kept up to date
Evaluation of Robotic-assisted Mitral Surgery With the daVinci X Surgical System
NCT04415138 · Cliniche Humanitas Gavazzeni · Updated 4 June 2020
- What is being tested
- Robotic-assisted mitral valve repair
- For
- Mitral Regurgitation; Surgery
- Kind of study
- Watches patients without assigning a treatment. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 250 people. The full rules are on the registry page.
- Where
- Italy
- When
- Starts or started 10 March 2020, ends 30 June 2023. Registered 4 June 2020.
- Results
- None posted yet.
In the researchers' words
Robotic assistance allows performance of mitral valve operations with a truly minimally invasive and totally thoracoscopic approach, with significant advantages for patients compared to sternotomy-based surgery. Nonetheless, its diffusion has been limited by: 1) significant learning curve and technical requirements; 2) increased immediate financial costs due to dedicated equipment and materials. The aim of the present study is to perform a prospective data collection and evaluation of the in-hospital and follow-up clinical results of mitral valve repair using the last generation DaVinci X robotic platform. A cost-effectiveness analysis of this approach will be also conducted, under a global healthcare system perspective (including the overall patients' pathway starting from diagnosis of mitral valve disease until the completion of the 1st postoperative year). Since the 'competitor' surgical technique is not represented by sternotomy-based mitral surgery, but instead by minimally invasive, video-assisted mitral surgery, patients operated on using such technique will serve as controls.
Sites
- Cliniche HUMANITAS GavazzeniBergamo, Italy
