Novel ICD Arrhythmia Detection Algorithm

• Sponsor: Imperial College London (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04981496
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 27
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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 we will collect data from patients 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 patients we will also collect further data from a small loop recorder implanted under the skin.

We 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. We aim to recruit 100 patients in total.

Condition or Disease	Intervention/Treatment	Phase
ICD; Implantable Defibrillator User; Cardiomyopathies

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 Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Improving Implantable Cardioverter-defibrillator Arrhythmia Detection: Development of a Novel Arrhythmia Detection Algorithm
• Actual Study Start Date: Jul 6, 2021
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Oct 7, 2023

Arms and Interventions

Arm	Intervention/Treatment
Study A: ILR implantation These are participants attending hospital for a clinically indicated ICD/CRT-D implantation or box change who will undergo rapid atrial and ventricular pacing to simulate arrhythmias and RV lead noise simulation and have an ILR implanted during their procedure.
Study B: ICD implantation These are participants attending hospital for a clinically indicated ICD/CRT-D implantation or box change who will undergo rapid atrial and ventricular pacing to simulate arrhythmias and RV lead noise simulation who will not have an ILR implanted.
Study C: VT Ablation These are participants having a clinically indicated VT ablation who we will record ventricular arrhythmias during the procedure.
Study D: Exercise Treadmill Test These are participants who already have a cardioverter defibrillator implanted who can safely exercise and bring up their heart rate.
Study E: Spontaneous Arrhythmias These are participants who already have a cardioverter defibrillator implanted and come into hospital with an atrial or ventricular arrhythmia.

Outcome Measures

Primary Outcome Measures

1. Outperforming current arrhythmia detection algorithms [3 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hammersmith Hospital	London		United Kingdom	W12 0HS

Sponsors and Collaborators

• Imperial College London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT04981496
• Other Study ID Numbers: 20HH5882; FS/20/11/34750
• First Posted: Jul 29, 2021
• Last Update Posted: Jul 29, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Imperial College London: ICD; arrhythmia; algorithm; haemodynamic sensor; bipolar electrogram
• Additional relevant MeSH terms: Cardiomyopathies; Arrhythmias, Cardiac

Study Results

No Results Posted as of Jul 29, 2021