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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.
ClinicalTrials.gov, NCT04415138

Sites

  • Cliniche HUMANITAS GavazzeniBergamo, Italy