Novel ICD Arrhythmia Detection Algorithm

NCT04981496 | Unknown

• 2 other identifiers: 20HH5882FS/20/11/34750
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ICD; arrhythmia; algorithm; haemodynamic sensor; bipolar electrogram

Outcome Measures

Primary Outcomes (1)

• Outperforming current arrhythmia detection algorithms

  Improvement in sensitivity and specificity in accurately detecting ventricular arrhythmias in comparison to current algorithms. sensor and a separate electrical signal can out-perform current implantable cardioverter defibrillator algorithms. We will run different simulated and genuine arrhythmias through our novel detection algorithm and compare it against detection algorithms from all the major manufacturers with devices programmed as per HRS primary prevention guidelines.

  3 years

Study Arms (2)

Simulated Arrhythmias

Simulate ventricular and/or atrial tachycardia via VVI or AAI pacing an ICD with an implantable loop recorder implant (or a surface bipolar electrogram) and haemodynamics.

Other: Observational Study during Clinical and Simulated arrhythmias in patients with ICDs

Clinical Arrhythmias

Genuine clinical VT (acute presentation), RV lead fracture/noise or sinus tachycardia on exercise whilst recording haemodynamics and a surface bipolar electrogram.

Other: Observational Study during Clinical and Simulated arrhythmias in patients with ICDs

Interventions

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

Observational Study during Clinical and Simulated arrhythmias in patients with ICDs

Clinical Arrhythmias; Simulated Arrhythmias

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study A and B Patients who are having a clinically indicated ICD implantation or its battery replaced. Study C Patients who already have an ICD implanted and are undergoing a clinically indicated VT ablation. Study D Patients who already have an ICD implanted and are able to safely raise their heart rates through exercise. Study E Patients who already have an ICD implanted and attend hospital with a spontaneous arrhythmia.

You may qualify if:

• Study A and B
• Patients referred for conventional defibrillator implantation or generator change.
• Adults (age \> 18 years)
• Willing to take part and able to give consent.
• Study C
• Patients with defibrillators who are undergoing a VT ablation.
• Adults (age \> 18 years)
• Willing to take part and able to give consent.
• Study D
• Patients with defibrillators already implanted who are able to exercise and raise their heart rate substantially
• Adults (age \> 18 years)
• Willing to take part and able to give consent.
• Study E
• Patients with a defibrillator already implanted admitted with atrial arrhythmias, ventricular tachycardia or RV lead fracture.
• Adults (age \> 18 years)

You may not qualify if:

• Unable to give consent.
• Children (age \< 18 years)
• Pregnant women.
• Intracardiac thrombus
• AF without regular anticoagulation
• Severe aortic stenosis
• Severe ischaemic heart disease
• Decompensated heart failure
• Recent heart attack or stroke (within the last month)
• Thromboembolic event undergoing active treatment
• Severe aortic stenosis
• Severe ischaemic heart disease
• Hypertrophic obstructive cardiomyopathy
• Uncontrolled ventricular arrhythmias
• Physically unable to exercise, for example due to arthritis.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Cardiomyopathies; Arrhythmias, Cardiac

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: July 29, 2021
• Study Start: July 6, 2021
• Primary Completion: October 1, 2023
• Study Completion: May 1, 2024
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

GB (1)