Cardiac SurgeryNCT07533214
Impact of Left-Handed Tailored Endoscopic Mitral Simulation Training on Skill Acquisition for Left-handed Surgeons
A study testing Endoscopic annular suture placement guided by left handed instructor in people with Cardiac Surgery and Training, run by Academisch Ziekenhuis Maastricht at 1 site in Portugal.
Trial summary
Study Characteristics and Structure are as follows: All Left-handed cardiac surgeons and residents attending the 2024 EACTS annual meeting (october 2024) are invited to any of the 3-day 8-endoscopic sessions as part of this study trial. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Surgery, Training, Suture
- What is being tested?
- Endoscopic annular suture placement guided by left handed instructor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 9 Oct 2024to 12 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Left handed cardiac surgeons and residents
Who cannot join
- experienced endoscopic left handed surgeons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Study Characteristics and Structure are as follows:
All Left-handed cardiac surgeons and residents attending the 2024 EACTS annual meeting (october 2024) are invited to any of the 3-day 8-endoscopic sessions as part of this study trial. The Left-handed cardiac surgeons and residents may participte in any of the sessions which best fits their schedule. Time frame includes all three days of endoscopic simulation sessions as walk-ins according to the availability of each surgeon. The exclusion criteria will be experienced endoscopic left-handed surgeons who are already experts. Left-handed surgeons will be randomized to either the standard right-handed guided simulation training session or to a Left-handed tailored simulation session.
Read more
Study Intervention: Left-handed surgeons and residents will be randomized to either a 2-hour Left-handed tailored-guided session (Group 1) or a standard right-handed guided 2-hour endoscopic simulation training session (Group 2).
Setting: EACTS 2024 annual meeting (october 2024 - 3-day convention)
Group 1 will be guided by a left-handed intructor using Left-handed endoscopic suture maps Group 2 will be guided by a right-handed intructor using Standard right-handed suture maps
Pre-course tests will evaluate accuracy and time of endoscopic suture placement in comparison to post-course tests to assess improvements. Pre-session assessments will be carried out evaluating endoscopic suture placement accuracy and time to suture placement. These include:
- Time to suture placement under <60 seconds
- Accuracy of suture placement considered to be between 2-8 mm
- Suture placement locations will be both Anterior and Posterior annular placements
Post-skills sessions assessment: finalizing the 2-hour workshop the participants will be asked to repeat both the anterior and posterior annular endoscopic suture placement.
Final study evaluations and delta time comparisons will be performed to determine if Left-handed surgeons guided by left-handed surgeons outperform or at least fair better then when guided by right-handed instructors.
Read the detailed description
Determine if during endoscopic simulation training the pairing of LH surgeons with LH instructors will outperform LH surgeons guided by right-handed intructors.
Determine whether LH surgeons guided by right-handed instructors on simulation training fair worse against Right-handed to right handed simulation training.
We hypothesize that the pairing of same dexterity tailored training will improve endoscopic skill performance.
- Conditions
- Cardiac Surgery, Training, Suture, Left-handed
- Being tested
- Endoscopic annular suture placement guided by left handed instructor
- Keywords
- cardiac, left-hand, simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic annular suture placement guided by left handed instructorProcedure or surgery
Endoscopic suture placement efficiency guided by left hamded instructors
| Study group | Role | What they receive |
|---|---|---|
| Left-handed surgeons with left-handed instructors | Active comparator | Determine if during endoscopic simulation training the pairing of LH surgeons with LH instructors will outperform LH surgeons guided by right-handed intructors. Receives: Procedure: Endoscopic annular suture placement guided by left handed instructor |
| Left-handed surgeons with right-handed instructor | No intervention | Determine whether LH surgeons guided by right-handed instructors on simulation training fair worse against Right-handed to right handed simulation training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta time difference of suture placement
Final study evaluations and delta time comparisons will be performed to determine if Left-handed surgeons guided by left-handed surgeons outperform or at least fair better then when guided by right-handed instructors.
Study Objectives:
Determine if during endoscopic simulation training the pairing of LH surgeons with LH instructors will outperform LH surgeons guided by right-handed intructors.
Determine whether LH surgeons guided by right-handed instructors on simulation training fair worse against Right-handed to right handed simulation training.
We hypothesize that the pairing of same dexterity tailored training will improve endoscopic skill performance.
Measured: From the randomisation (start of the training) to the end of two-hours training
improvement in seconds taken to perform mitral suturing
time duration it takes to successfully place mitral annular sutures on simulators
Measured: this will be performed during a two hour course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start9 Oct 2024
- Primary completion12 Oct 2025
- Study completion12 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Left-handed surgeons trained by left -handed instructors
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Ziekenhuis Maastricht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peyman Sardari Nia, Academisch Ziekenhuis Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533214
- Sponsor's protocol ID
- 2024-0391
- Status last verified
- Apr 2026
- First submitted
- 2 Oct 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants will be anonymous
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Left-Handed Tailored Endoscopic Mitral Simulation Training on Skill Acquisition for Left-handed Surgeons
- ClinicalTrials.gov ID
- NCT07533214
- Acronym / sponsor ID
- 2024-0391
- Conditions
- Cardiac Surgery, Training, Suture, Left-handed
- Keywords
- cardiac, left-hand, simulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Academisch Ziekenhuis MaastrichtUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 12 Oct 2025 (actual)
- Study completion
- 12 Oct 2026 (estimated)
- First posted
- 16 Apr 2026 (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.
Study Characteristics and Structure are as follows:
All Left-handed cardiac surgeons and residents attending the 2024 EACTS annual meeting (october 2024) are invited to any of the 3-day 8-endoscopic sessions as part of this study trial. The Left-handed cardiac surgeons and residents may participte in any of the sessions which best fits their schedule. Time frame includes all three days of endoscopic simulation sessions as walk-ins according to the availability of each surgeon. The exclusion criteria will be experienced endoscopic left-handed surgeons who are already experts. Left-handed surgeons will be randomized to either the standard right-handed guided simulation training session or to a Left-handed tailored simulation session.
Study Intervention: Left-handed surgeons and residents will be randomized to either a 2-hour Left-handed tailored-guided session (Group 1) or a standard right-handed guided 2-hour endoscopic simulation training session (Group 2).
Setting: EACTS 2024 annual meeting (october 2024 - 3-day convention)
Group 1 will be guided by a left-handed intructor using Left-handed endoscopic suture maps Group 2 will be guided by a right-handed intructor using Standard right-handed suture maps
Pre-course tests will evaluate accuracy and time of endoscopic suture placement in comparison to post-course tests to assess improvements. Pre-session assessments will be carried out evaluating endoscopic suture placement accuracy and time to suture placement. These include:
- Time to suture placement under <60 seconds
- Accuracy of suture placement considered to be between 2-8 mm
- Suture placement locations will be both Anterior and Posterior annular placements
Post-skills sessions assessment: finalizing the 2-hour workshop the participants will be asked to repeat both the anterior and posterior annular endoscopic suture placement.
Final study evaluations and delta time comparisons will be performed to determine if Left-handed surgeons guided by left-handed surgeons outperform or at least fair better then when guided by right-handed instructors.
Detailed description
Determine if during endoscopic simulation training the pairing of LH surgeons with LH instructors will outperform LH surgeons guided by right-handed intructors.
Determine whether LH surgeons guided by right-handed instructors on simulation training fair worse against Right-handed to right handed simulation training.
We hypothesize that the pairing of same dexterity tailored training will improve endoscopic skill performance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Left-handed surgeons trained by left -handed instructors
| Arm | Type | Receives |
|---|---|---|
| Left-handed surgeons with left-handed instructors | Active comparator | Procedure: Endoscopic annular suture placement guided by left handed instructorDetermine if during endoscopic simulation training the pairing of LH surgeons with LH instructors will outperform LH surgeons guided by right-handed intructors. |
| Left-handed surgeons with right-handed instructor | No intervention | –Determine whether LH surgeons guided by right-handed instructors on simulation training fair worse against Right-handed to right handed simulation training. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Left handed cardiac surgeons and residents
Key exclusion criteria (1 listed)
- experienced endoscopic left handed surgeons
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 |
|---|---|---|
| Endoscopic annular suture placement guided by left handed instructorEndoscopic suture placement efficiency guided by left hamded instructors | Procedure or surgery | Left-handed surgeons with left-handed instructors |
Primary outcome
Delta time difference of suture placement
Time frame: From the randomisation (start of the training) to the end of two-hours training
Final study evaluations and delta time comparisons will be performed to determine if Left-handed surgeons guided by left-handed surgeons outperform or at least fair better then when guided by right-handed instructors. Study Objectives: Determine if during endoscopic simulation training the pairing of LH surgeons with LH instructors will outperform LH surgeons guided by right-handed intructors. Determine whether LH surgeons guided by right-handed instructors on simulation training fair worse against Right-handed to right handed simulation training. We hypothesize that the pairing of same dexterity tailored training will improve endoscopic skill performance.
improvement in seconds taken to perform mitral suturing
Time frame: this will be performed during a two hour course
time duration it takes to successfully place mitral annular sutures on simulators
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No. Participants will be anonymous
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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.
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?
A study testing Endoscopic annular suture placement guided by left handed instructor in people with Cardiac Surgery and Training, run by Academisch Ziekenhuis Maastricht at 1 site in Portugal.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 16 Apr 2026. 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 Portugal. 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?
This study is still under way. Results are not available in the source record yet.
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?
Delta time difference of suture placement (time frame: From the randomisation (start of the training) to the end of two-hours training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2026.