CClinicalTrials.gg
CompletedNCT05106582Updated Nov 3, 2021

Assessment of the Learning Curve of Total Thoracoscopic Mitral Valve Repair

An observational study in Total Thoracoscopic Mitral Valve Plasty; Minimally Invasive; Learning Curve, sponsored by Yunlong Fan. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-03.

Sponsored by Yunlong Fan · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study summary

Total thoracoscopic mitral valve plasty (MVP) is characterized by minimal trauma, minimal bleeding, and short postoperative recovery time. The learning curve of any new procedure needs to be evaluated for learning and replication.Using Cardiopulmonary bypass (CPB) time and Aortic clamping (AC) time as evaluation variables, we visualized the learning curve for total thoracoscopic MVP using Cumulative sum analysis. We also analyzed important postoperative variables such as postoperative drainage, duration of mechanical ventilation, ICU stay and postoperative hospital stay.

The retrospective study comprised 150 consecutive patients who underwent total thoracoscopic MVP from October 2017 to July 2021.

02

Conditions studied

  • Total Thoracoscopic Mitral Valve Plasty; Minimally Invasive; Learning Curve
03

In context

Lead sponsor

Yunlong Fan is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

age over 18 years who underwent total thoracoscopic MVP without concurrent cardiac Surgery

Inclusion criteria

  • age over 18 years who underwent total thoracoscopic MVP without concurrent cardiac Surgery

Exclusion criteria

Exclusion Criteria:

  • data miss greater than 10%
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
150 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Cardiopulmonary bypass (CPB) time

    Cardiopulmonary bypass (CPB) time was used as the main variables for evaluation and visualization of the total thoracoscopic mitral valve plasty (MVP) learning curve using Cumulative sum.Cumulative sum (CUSUM) is a statistical method that focuses on results rather than on the process of performing a program skills, it generates graphs that allow for quick detection of deviations from pre-established standards and is an alternative tool that can be used to evaluate the performance of individual program. CUSUM can be generated based on set acceptable and unacceptable failure rates and the degree to which type 1(α) and type 2(β) errors (false positive and false negative errors) will be tolerated. CUSUM was defined as Sn = ∑(Xi -p0), where Xi = 0 for success and Xi = 1 for failure, p0 is the target reference.

    Time frame: Intra-operative

  2. Aortic clamping (AC) time

    Aortic clamping (AC) time was used as the main variables for evaluation and visualization of the total thoracoscopic mitral valve plasty (MVP) learning curve using Cumulative sum.Cumulative sum (CUSUM) is a statistical method that focuses on results rather than on the process of performing a program skills, it generates graphs that allow for quick detection of deviations from pre-established standards and is an alternative tool that can be used to evaluate the performance of individual program. CUSUM can be generated based on set acceptable and unacceptable failure rates and the degree to which type 1(α) and type 2(β) errors (false positive and false negative errors) will be tolerated. CUSUM was defined as Sn = ∑(Xi -p0), where Xi = 0 for success and Xi = 1 for failure, p0 is the target reference.

    Time frame: Intra-operative

07

Study locations

1 site
  • Chinese PLA General hospital
    Beijing, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05106582
Lead sponsor
Yunlong Fan
Responsible party
Yunlong Fan (Clinical Professor, Chinese PLA General Hospital) — Sponsor-investigator
First posted
Nov 3, 2021
Start date
Oct 1, 2017
Primary completion
Aug 1, 2021
Completion
Aug 1, 2021
Last update
Nov 3, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion