Educational Problems Clinical Trial
Official title:
Development and Validation of Performance Metrics for Cardiac Device
Verified date | July 2018 |
Source | Liverpool Heart and Chest Hospital NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Cardiac Device implantation includes implantation of pacemakers, implantable defibrillators
and Cardiac resynchronisation Therapy (CRT) devices. These are well-established treatments
for selected with heart rhythm abnormalities and heart failure.
In the past, trainee doctors had the opportunity to perform many procedures and learn on the
patient. This is no longer the case due to a change in training schedules and working times
as well as patient safety mandates. Progression based training with the use of simulators has
been proven to be effective in training and in order to use this methodology, the procedure
needs to be well defined.
Despite its worldwide adoption, a standardized procedure has never been defined in detail and
agreed upon and the cardiac device implant technique varies with the operator.
The purpose of the research is to establish the metrics (operational definitions) necessary
to characterize a reference Cardiac Device implant procedure.
Status | Not yet recruiting |
Enrollment | 16 |
Est. completion date | May 30, 2019 |
Est. primary completion date | December 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Patients eligible for a cardiac device implant as per current European Society of Cardiology guidelines. Exclusion Criteria: Patient< 18 y of age. Patients unable to provide informed written consent for the study. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Liverpool Heart and Chest Hospital NHS Foundation Trust | Medtronic |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome measure is the comparison of the intra-operative performance of novices versus experts | The primary analysis will compare the intra-operative performance of novices versus experts. The three experienced cardiac device implanters will test the consented metrics by reviewing and scoring the video recorded procedures to verify that the metrics distinguish between a novice and an expert cardiac device performance. IRR will be considered to be acceptable if it is = 0.8 The primary analysis will compare the intra-operative performance of novices versus experts. The three experienced cardiac device implanters will test the consented metrics by reviewing and scoring the video recorded procedures to verify that the metrics distinguish between a novice and an expert cardiac device performance. IRR will be considered to be acceptable if it is = 0.8 |
6 months |
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