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| ID | Type | Description | Link |
|---|---|---|---|
| FS/20/11/34750 | Other Grant/Funding Number | BHF |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Clinical Arrhythmias | Genuine clinical VT (acute presentation), RV lead fracture/noise or sinus tachycardia on exercise whilst recording haemodynamics and a surface bipolar electrogram. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational Study during Clinical and Simulated arrhythmias in patients with ICDs | Other | Observational Study during Clinical and Simulated arrhythmias in patients with ICDs |
|
| 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 |
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Inclusion Criteria:
Study A and B
Study C
Study D
Study E
Exclusion Criteria:
Exclusion criteria for studies A-E:
Exclusion criteria for studies A and B if undergoing VF induction:
Exclusion criteria for study D
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Hospital | London | W12 0HS | United Kingdom |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 15, 2025 | |
| Reset | Feb 6, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 15, 2025 | Feb 6, 2025 |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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| D004567 |
| Electrodes, Implanted |
| D019736 | Prostheses and Implants |