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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03577340
Other study ID # 1189
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date May 30, 2019

Study information

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

Clinical Trial Summary

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.


Description:

The purpose of the research is to establish the metrics (operational definitions) necessary to characterize a reference Cardiac Device implant procedure, to seek consensus from experienced device implanters on the appropriateness of the steps as well as errors identified, and to determine if such validated performance metrics are a valid assessment tool with the ability to discriminate between the performances of experienced and novice implanters.

These validated metrics will potentially serve as an educational and training tool to improve and quality assure Cardiac device implant training.

The steps involved in characterising a reference procedure are as follows:

1. Define the implant procedure in quantifiable steps (already performed)

2. Seek consensus and agreement by an independent panel on the steps (already done).

3. Video record routinely performed device implants by experienced and novice physicians.

4. Reviewing and scoring the video recorded procedures to verify that the metrics distinguish between a novice and an expert cardiac device performance.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
implant of cardiac device as per guidelines
Observation of performance to validate matrix

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Liverpool Heart and Chest Hospital NHS Foundation Trust Medtronic

Outcome

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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