Development & Validation of Performance Metrics for Cardiac Device Implant

Status Not yet recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Educational Problems

Clinical Trial Details

NCT number	NCT03577340
Study type	Observational
Source	Liverpool Heart and Chest Hospital NHS Foundation Trust
Contact
Status	Not yet recruiting
Phase
Start date	September 1, 2018
Completion date	May 30, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Development and Validation of Performance Metrics for Cardiac Device Implant Procedures

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms