Mitral RegurgitationNCT04415138
Evaluation of Robotic-assisted Mitral Surgery With the daVinci X Surgical System
An observational study of Mitral Regurgitation and Surgery, run by Cliniche Humanitas Gavazzeni at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Surgery
- What is being tested?
- Robotic-assisted mitral valve repair
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 10 Mar 2020to 30 Jun 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mitral Regurgitation, Surgery
- Being tested
- Robotic-assisted mitral valve repair
- Keywords
- Robotic Surgery, Outcomes, Cost analysis
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted mitral valve repairDevice
Mitral valve repair using robotic technology (DaVinci X platform)
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted Group | Not described Receives: Device: Robotic-assisted mitral valve repair | |
| Video-assisted Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of ICU stay (hours) and Hospital stay (days and hours)
Duration of stay inside healthcare facility providing index operation. Average value and standard deviation will be presented.
Measured: Up to 30 days after index surgery.
Rate of Major Adverse Cerebral and Cardiovascular Events (MACCE)
Rate of stroke/TIA, myocardial infarction, cardiac reoperation (presented through both individual and aggregated rates).
Measured: Day of index surgery until 30th postoperative day or discharge
Economic evaluation (direct and indirect costs).
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).
Measured: Up to 90 days after index surgery.
Secondary outcomes (2)
Rate of residual mitral regurgitation (Early).
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.
Measured: Up to 60 days after index surgery.
Rate of residual mitral regurgitation (follow-up).
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.
Measured: From the 3rd until the 12th month after index surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start10 Mar 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Cliniche Humanitas Gavazzeni
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfonso Agnino, Cliniche Humanitas Gavazzeni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415138
- Sponsor's protocol ID
- GAV 213/20
- Status last verified
- May 2020
- First submitted
- 21 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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.
PubMed 15942584Agnino 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.
PubMed 28606395Rodriguez 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.
PubMed 27343904Gillinov 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.
PubMed 28893396Hawkins 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.
PubMed 29915143Suri 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.
PubMed 24079678Agnino 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.
PubMed 30601192Agnino 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.
PubMed 32380519
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04415138
- Acronym / sponsor ID
- GAV 213/20
- Conditions
- Mitral Regurgitation, Surgery
- Keywords
- Robotic Surgery, Outcomes, Cost analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Cliniche Humanitas GavazzeniUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted Group | – | Device: Robotic-assisted mitral valve repair |
| Video-assisted Group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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+.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-assisted mitral valve repairMitral valve repair using robotic technology (DaVinci X platform) | Device | Robotic-assisted Group |
Primary outcome
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.
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).
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).
2 secondary outcomes
Rate of residual mitral regurgitation (Early).
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Results publication: PubMed 15942584Nifong 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.
- Results publication: PubMed 28606395Agnino 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.
- Results publication: PubMed 27343904Rodriguez 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.
- Results publication: PubMed 28893396Gillinov 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.
- Results publication: PubMed 29915143Hawkins 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.
- Results publication: PubMed 24079678Suri 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.
- Results publication: PubMed 30601192Agnino 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.
- Results publication: PubMed 32380519Agnino 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.
- Individual participant dataSharing planned: Undecided
Related trials for Mitral Regurgitation
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Recruiting
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
Mitral Regurgitation, Mitral Valve Disease
Not yet recruitingObservational study
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
Mitral Valve Insufficiency
Recruiting
Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation
Heart Failure - NYHA II - IV, Mitral Regurgitation Functional
Not yet recruiting
Early Feasibility Study of the Capstan Medical TMVR System
Mitral Regurgitation (MR)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation and Surgery, run by Cliniche Humanitas Gavazzeni at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of ICU stay (hours) and Hospital stay (days and hours) (time frame: Up to 30 days after index surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04415138, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.