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

May 30, 2020 updated by: Alfonso Agnino, Cliniche Humanitas Gavazzeni

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)

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.

Study Overview

Status

Active, not recruiting

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

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bergamo, Italy, 24125
        • Cliniche Humanitas Gavazzeni

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients affected by severe mitral regurgitation due to degenerative disease (Leaflet prolapse/flail) with indication to surgical mitral repair using either a robotic-assisted approach or a minimally invasive video-assisted non-robotic-assisted approach. Includes patients referred to a tertiary cardiac surgical centre.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Robotic-assisted Group
Mitral valve repair using robotic technology (DaVinci X platform)
Video-assisted Group

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.
Duration of stay inside healthcare facility providing index operation. Average value and standard deviation will be presented.
Up to 30 days after index surgery.
Rate of Major Adverse Cerebral and Cardiovascular Events (MACCE)
Time Frame: Day of index surgery until 30th postoperative day or discharge
Rate of stroke/TIA, myocardial infarction, cardiac reoperation (presented through both individual and aggregated rates).
Day of index surgery until 30th postoperative day or discharge
Economic evaluation (direct and indirect costs).
Time Frame: Up to 90 days after index surgery.
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).
Up to 90 days after index surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of residual mitral regurgitation (Early).
Time Frame: Up to 60 days after index surgery.
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.
Up to 60 days after index surgery.
Rate of residual mitral regurgitation (follow-up).
Time Frame: From the 3rd until the 12th month after index surgery.
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.
From the 3rd until the 12th month after index surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

May 21, 2020

First Submitted That Met QC Criteria

May 30, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

May 30, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • GAV 213/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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