- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04415138
Evaluation of Robotic-assisted Mitral Surgery With the daVinci X Surgical System
Prospective Evaluation of Robotic-assisted Mitral Surgery With the daVinci X Surgical System: HUMANITAS Gavazzeni Contribution (Studio Dell'Applicazione Della Chirurgia Robotica Con Robot daVinci X (IS4200) di Ultima Generazione Sulla Valvulopatia Mitralica: Contributo di HUMANITAS Gavazzeni)
Study Overview
Status
Conditions
Intervention / Treatment
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 the study period will be collected, including preoperative, intraoperative and early postoperative variables. Patients need to be affected by severe mitral regurgitation due to degenerative lesions and be eligible to robotic-assisted surgery. An informed consent for inclusion in the study and management of personal data will be asked from all participants. A total of 30 Baseline variables, 9 intraoperative variables, 26 early postoperative variables and 55 follow-up variables will be collected. Systematic in-house follow-up (clinical and echocardiographic) will be performed at the 3rd, 6th and 12th postoperative months. The database will be managed by research assistants under the supervision of the surgical team. Operations will be performed according to the Institutional protocol using the DaVinci X robotic platform by a trained multidisciplinary team including cardiac surgeons, anesthesiologists, cardiologists, perfusionists and scrub nurses.
The same data will be obtained for all patients undergoing minimally invasive, video-assisted non-robotic-assisted mitral repair during the study period. These patients will serve as controls.
Study Endpoints will include procedural success, early postoperative complications, postoperative functional recovery (both immediate and at follow-up), echocardiographic results of mitral repair.
Such data will be compared with those from control patients undergoing minimally invasive, non-robotic-assisted mitral surgery in our Department during the study period.
In cooperation with Hospital Administration Team, all direct and indirect costs (Euros) associated with the in-hospital pathway of each individual patient will be quantified (17 variables per patient within a separate database). Data collection will be expanded to any hospitalisation occurring during the 1st postoperative year. Such data collection will include patients undergoing both the robotic-assisted and the minimally invasive video-assisted non-robotic-assisted strategy.
Data will be analysed using intergoup comparison statistical tests.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Bergamo, Italy, 24125
- Cliniche Humanitas Gavazzeni
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Robotic-assisted Group
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Mitral valve repair using robotic technology (DaVinci X platform)
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Video-assisted Group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of ICU stay (hours) and Hospital stay (days and hours)
Time Frame: Up to 30 days after index surgery.
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Duration of stay inside healthcare facility providing index operation.
Average value and standard deviation will be presented.
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Up to 30 days after index surgery.
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Rate of Major Adverse Cerebral and Cardiovascular Events (MACCE)
Time Frame: Day of index surgery until 30th postoperative day or discharge
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Rate of stroke/TIA, myocardial infarction, cardiac reoperation (presented through both individual and aggregated rates).
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Day of index surgery until 30th postoperative day or discharge
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Economic evaluation (direct and indirect costs).
Time Frame: Up to 90 days after index surgery.
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Direct and indirect costs associated with robotic-assisted mitral surgery.
These will be evaluated for each individual patient and expressed in Euros, under the form of average value and standard deviation.
Direct costs will be categorized as follows: total supplies, total drugs, unit operating costs, unit supporting costs).
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Up to 90 days after index surgery.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of residual mitral regurgitation (Early).
Time Frame: Up to 60 days after index surgery.
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Data will be obtained from pre-discharge echocardiography.
Residual Mitral Regurgitation is defined as being at least of degree 2+/4+ according to current Echocardiography recommendations.
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Up to 60 days after index surgery.
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Rate of residual mitral regurgitation (follow-up).
Time Frame: From the 3rd until the 12th month after index surgery.
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Data will be obtained from echocardiography performed at the 3rd, 6th and 12th postoperative months.
Residual Mitral Regurgitation is defined as being at least of degree 2+/4+ according to current Echocardiography recommendations.
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From the 3rd until the 12th month after index surgery.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Nifong LW, Chitwood WR, Pappas PS, Smith CR, Argenziano M, Starnes VA, Shah PM. Robotic mitral valve surgery: a United States multicenter trial. J Thorac Cardiovasc Surg. 2005 Jun;129(6):1395-404. doi: 10.1016/j.jtcvs.2004.07.050.
- Agnino A, Parrinello M, Panisi P, Anselmi A. Novel nonresectional posterior leaflet remodeling approach for minimally invasive mitral repair. J Thorac Cardiovasc Surg. 2017 Oct;154(4):1247-1249. doi: 10.1016/j.jtcvs.2017.04.076. Epub 2017 May 23. No abstract available.
- Rodriguez E, Nifong LW, Bonatti J, Casula R, Falk V, Folliguet TA, Kiaii BB, Mack MJ, Mihaljevic T, Smith JM, Suri RM, Bavaria JE, MacGillivray TE, Chitwood WR Jr. Pathway for surgeons and programs to establish and maintain a successful robot-assisted adult cardiac surgery program. J Thorac Cardiovasc Surg. 2016 Jul;152(1):9-13. doi: 10.1016/j.jtcvs.2016.05.018. No abstract available.
- Gillinov AM, Mihaljevic T, Javadikasgari H, Suri RM, Mick SL, Navia JL, Desai MY, Bonatti J, Khosravi M, Idrees JJ, Lowry AM, Blackstone EH, Svensson LG. Early results of robotically assisted mitral valve surgery: Analysis of the first 1000 cases. J Thorac Cardiovasc Surg. 2018 Jan;155(1):82-91.e2. doi: 10.1016/j.jtcvs.2017.07.037. Epub 2017 Aug 1.
- Hawkins RB, Mehaffey JH, Mullen MG, Nifong WL, Chitwood WR, Katz MR, Quader MA, Kiser AC, Speir AM, Ailawadi G; Investigators for the Virginia Cardiac Services Quality Initiative. A propensity matched analysis of robotic, minimally invasive, and conventional mitral valve surgery. Heart. 2018 Dec;104(23):1970-1975. doi: 10.1136/heartjnl-2018-313129. Epub 2018 Jun 18.
- Suri RM, Thompson JE, Burkhart HM, Huebner M, Borah BJ, Li Z, Michelena HI, Visscher SL, Roger VL, Daly RC, Cook DJ, Enriquez-Sarano M, Schaff HV. Improving affordability through innovation in the surgical treatment of mitral valve disease. Mayo Clin Proc. 2013 Oct;88(10):1075-84. doi: 10.1016/j.mayocp.2013.06.022.
- Agnino A, Antonazzo A, Albano G, Panisi P, Gerometta P, Piti A, Anselmi A. Strategy-specific durability of mitral valve repair through the video-assisted right minithoracotomy approach. J Cardiovasc Med (Hagerstown). 2019 Mar;20(3):137-144. doi: 10.2459/JCM.0000000000000753.
- Agnino A, Graniero A, Roscitano C, Villari N, Marvelli A, Verhoye JP, Anselmi A. Continued follow-up of the free margin running suture technique for mitral repair. Eur J Cardiothorac Surg. 2020 Oct 1;58(4):847-854. doi: 10.1093/ejcts/ezaa122.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GAV 213/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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