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Evaluation of Robotic-assisted Mitral Surgery With the daVinci X Surgical System

NCT04415138 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2020-06-04

No results posted yet for this study

Summary

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.

Conditions

  • Mitral Regurgitation
  • Surgery

Interventions

DEVICE

Robotic-assisted mitral valve repair

Mitral valve repair using robotic technology (DaVinci X platform)

Sponsors & Collaborators

  • Cliniche Humanitas Gavazzeni

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-10
Primary Completion
2022-12-31
Completion
2023-06-30
FDA Device
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04415138 on ClinicalTrials.gov