Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
90 participants
OBSERVATIONAL
2021-07-06
2024-05-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
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.
Observational Study during Clinical and Simulated arrhythmias in patients with ICDs
Observational Study during Clinical and Simulated arrhythmias in patients with ICDs
Interventions
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Observational Study during Clinical and Simulated arrhythmias in patients with ICDs
Observational Study during Clinical and Simulated arrhythmias in patients with ICDs
Eligibility Criteria
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Inclusion Criteria
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
2. Children (age \< 18 years)
3. Pregnant women.
1. Intracardiac thrombus
2. AF without regular anticoagulation
3. Severe aortic stenosis
4. Severe ischaemic heart disease
5. Decompensated heart failure
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.
18 Years
99 Years
ALL
No
Sponsors
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Imperial College London
OTHER
Responsible Party
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Locations
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Hammersmith Hospital
London, , United Kingdom
Countries
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Other Identifiers
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FS/20/11/34750
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
20HH5882
Identifier Type: -
Identifier Source: org_study_id