Novel ICD Arrhythmia Detection Algorithm

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiomyopathies; Implantable Defibrillator User; ICD
• Intervention / Treatment: Other: Observational Study during Clinical and Simulated arrhythmias in patients with ICDs

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.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

• Study Contact: Name: Alejandra A Miyazawa, MBChB; Phone Number: 07511002203; Email: a.miyazawa@imperial.ac.uk
• Study Contact Backup: Name: Zachary I Whinnett; Phone Number: 0203 313 3000; Email: z.whinnett@imperial.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, W12 0HS
    • Hammersmith Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

Study A and B

1. Patients referred for conventional defibrillator implantation or generator change.
2. Adults (age > 18 years)
3. Willing to take part and able to give consent.

Study C

1. Patients with defibrillators who are undergoing a VT ablation.
2. Adults (age > 18 years)
3. Willing to take part and able to give consent.

Study D

1. Patients with defibrillators already implanted who are able to exercise and raise their heart rate substantially
2. Adults (age > 18 years)
3. Willing to take part and able to give consent.

Study E

1. Patients with a defibrillator already implanted admitted with atrial arrhythmias, ventricular tachycardia or RV lead fracture.
2. Adults (age > 18 years)
3. Willing to take part and able to give consent.

Exclusion Criteria:

Exclusion criteria for studies A-E:

1. Unable to give consent.
2. Children (age < 18 years)
3. Pregnant women.

Exclusion criteria for studies A and B if undergoing VF induction:

1. Intracardiac thrombus
2. AF without regular anticoagulation
3. Severe aortic stenosis
4. Severe ischaemic heart disease
5. Decompensated heart failure

Exclusion criteria for study D

1. Recent heart attack or stroke (within the last month)
2. Thromboembolic event undergoing active treatment
3. Severe aortic stenosis
4. Severe ischaemic heart disease
5. Hypertrophic obstructive cardiomyopathy
6. Uncontrolled ventricular arrhythmias
7. Physically unable to exercise, for example due to arthritis.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; Observational Study during Clinical and Simulated arrhythmias in patients with ICDs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2021
• Primary Completion (Actual): October 1, 2023
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: algorithm; ICD; arrhythmia; haemodynamic sensor; bipolar electrogram
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiomyopathies
• Other Study ID Numbers: 20HH5882; FS/20/11/34750 (Other Grant/Funding Number: BHF)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No