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Development and Validation of Performance Metrics for Cardiac Device Implant Procedures

NCT03577340 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2018-07-05

No results posted yet for this study

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.

Conditions

  • Educational Problems

Interventions

OTHER

implant of cardiac device as per guidelines

Observation of performance to validate matrix

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2018-12-30
Completion
2019-05-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03577340 on ClinicalTrials.gov