Status:
UNKNOWN
Evaluation of Robotic-assisted Mitral Surgery With the daVinci X Surgical System
Lead Sponsor:
Cliniche Humanitas Gavazzeni
Conditions:
Mitral Regurgitation
Surgery
Eligibility:
All Genders
18+ years
Brief 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-bas...
Detailed Description
In an observational, prospective, case-control investigation, the clinical data of all adult (18 years-old or more) patients undergoing robotic-assisted mitral surgery in the Sponsor hospital during t...
Eligibility Criteria
Inclusion
- Aged at least 18, willing to complete the study follow-up, having signed the informed consent for participation and data management.
- Severe mitral regurgitation due to degenerative disease with indication to mitral repair surgery.
- If of female gender, being neither pregnant nor lactating.
Exclusion
- Previous right chest surgery or severe right intrapleural adhesions.
- Diameter of femoral arteries equal or lesser than 6 mm.
- Left ventricular systolic dysfunction (LVEF \<60%).
- Severe right ventricular dysfunction.
- Aortic valve regurgitation \>1+/4+.
- Pulmonary artery hypertension (PASP \>50 mmHg).
- Chest deformities preventing either robotic-assisted or minimally invasive video-assisted surgery.
Key Trial Info
Start Date :
March 10 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04415138
Start Date
March 10 2020
End Date
June 30 2023
Last Update
June 4 2020
Active Locations (1)
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1
Cliniche HUMANITAS Gavazzeni
Bergamo, Italy, 24125