Development and Validation of Performance Metrics for Cardiac Device Implant Procedures

NCT ID: NCT03577340

Last Updated: 2018-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-05-30

Brief 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.

Detailed 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.

Conditions

Educational Problems

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Novices

Novices: Trainee cardiologists implanting cardiac devices as per guidelines under supervision

implant of cardiac device as per guidelines

Intervention Type: OTHER

Observation of performance to validate matrix

Experts

Experts: Device implanting cardiologists implanting cardiac devices as per guidelines

implant of cardiac device as per guidelines

Intervention Type: OTHER

Observation of performance to validate matrix

Interventions

implant of cardiac device as per guidelines

Observation of performance to validate matrix

Intervention Type: OTHER

Eligibility Criteria

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.

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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Liverpool Heart and Chest Hospital NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Archana Rao

Consultant Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

1189

Identifier Type: -

Identifier Source: org_study_id