Novel ICD Arrhythmia Detection Algorithm

Cardiomyopathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04981496
• Other study ID #: 20HH5882
• Secondary ID: FS/20/11/34750
• Status: Active, not recruiting
• Start date: July 6, 2021
• Est. completion date: May 1, 2024

Study information

• Verified date: November 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: May 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiomyopathies
• ICD
• Implantable Defibrillator User

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Hammersmith Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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