NCT04981496

Novel ICD Arrhythmia Detection Algorithm

Improving Implantable Cardioverter-defibrillator Arrhythmia Detection: Development of a Novel Arrhythmia Detection Algorithm

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 90 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This novel arrhythmia detection algorithm will incorporate a haemodynamic sensor and extra bipolar electrogram with an aim to outperform current commercially used arrhythmia detection algorithms that rely primarily on heart rate.

Conditions

• ICD
• Implantable Defibrillator User
• Cardiomyopathies

Interventions

Type	Name	Description
OTHER	Observational Study during Clinical and Simulated arrhythmias in patients with ICDs	Observational Study during Clinical and Simulated arrhythmias in patients with ICDs

Timeline

• Start date: 2021-07-06
• Primary completion: 2023-10-01
• Completion: 2024-05-01
• First posted: 2021-07-29
• Last updated: 2023-12-01

Locations

1 site across 1 country: United Kingdom