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Novel ICD Arrhythmia Detection Algorithm

NCT04981496 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2023-12-01

No results posted yet for this study

Summary

Implantable cardioverter defibrillators (ICD) are used to treat life-threatening heart rhythm disturbances (arrhythmias).

They have been proven to reduce the risk of sudden cardiac death; however, there are limitations with current ICDs. Firstly, they may deliver inappropriate therapies (therapies delivered in the absence of life-threatening arrhythmias). Secondly, slower life-threatening arrhythmias may be left untreated because current programming recommendations, designed to minimise inappropriate therapies, rely predominantly on heart rates. Therefore, there is considerable potential to make ICDs safer with more sophisticated ICD algorithms.

In this research study the investigators will collect data from participants with newly implanted or existing ICDs whilst they are in induced or spontaneously occurring abnormal rhythms. The data will come from sensors placed on the skin that can measure blood flow or electrical properties of the body. In addition, in 20 participants, the investigators will also collect further data from a small loop recorder implanted under the skin.

The investigators will use this data to help develop and validate new methods of reliably identifying life-threatening arrhythmias so that future ICDs deliver therapies when only needed.

The research is funded by the British Heart Foundation, and will take place at Hammersmith Hospital over 3 years. The investigators aim to recruit 100 patients in total.

Conditions

  • ICD
  • Implantable Defibrillator User
  • Cardiomyopathies

Interventions

OTHER

Observational Study during Clinical and Simulated arrhythmias in patients with ICDs

Observational Study during Clinical and Simulated arrhythmias in patients with ICDs

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-06
Primary Completion
2023-10-01
Completion
2024-05-01

Countries

  • United Kingdom

Study Locations

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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 NCT04981496 on ClinicalTrials.gov