ICDNCT04981496
Novel ICD Arrhythmia Detection Algorithm
An observational study of ICD and Implantable Defibrillator User, run by Imperial College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- ICD, Implantable Defibrillator User, Cardiomyopathies
- What is being tested?
- Observational Study during Clinical and Simulated arrhythmias in patients with ICDs
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jul 2021to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Study A and B
- Patients referred for conventional defibrillator implantation or generator change.
- Adults (age > 18 years)
- Willing to take part and able to give consent.
- Study C
- Patients with defibrillators who are undergoing a VT ablation.
Show all 16Show fewer
- Adults (age > 18 years)
- Willing to take part and able to give consent.
- Study D
- Patients with defibrillators already implanted who are able to exercise and raise their heart rate substantially
- Adults (age > 18 years)
- Willing to take part and able to give consent.
- Study E
- Patients with a defibrillator already implanted admitted with atrial arrhythmias, ventricular tachycardia or RV lead fracture.
- Adults (age > 18 years)
- Willing to take part and able to give consent.
Who cannot join
- Unable to give consent.
- Children (age < 18 years)
- Pregnant women.
- Exclusion criteria for studies A and B if undergoing VF induction:
- Intracardiac thrombus
- AF without regular anticoagulation
Show all 16Show fewer
- Severe aortic stenosis
- Severe ischaemic heart disease
- Decompensated heart failure
- Recent heart attack or stroke (within the last month)
- Thromboembolic event undergoing active treatment
- Severe aortic stenosis
- Severe ischaemic heart disease
- Hypertrophic obstructive cardiomyopathy
- Uncontrolled ventricular arrhythmias
- Physically unable to exercise, for example due to arthritis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- ICD, Implantable Defibrillator User, Cardiomyopathies
- Being tested
- Observational Study during Clinical and Simulated arrhythmias in patients with ICDs
- Keywords
- ICD, arrhythmia, algorithm, haemodynamic sensor, bipolar electrogram
- Medical subject headings
- Cardiomyopathies, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Study during Clinical and Simulated arrhythmias in patients with ICDsOther
Observational Study during Clinical and Simulated arrhythmias in patients with ICDs
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 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. Receives: Other: Observational Study during Clinical and Simulated arrhythmias in patients with ICDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start6 Jul 2021
- Primary completion1 Oct 2023
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICDStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981496
- Sponsor's protocol ID
- 20HH5882
- Other IDs
- FS/20/11/34750
- Status last verified
- Nov 2023
- First submitted
- 19 Jul 2021
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Implantable Cardioverter-defibrillator Arrhythmia Detection: Development of a Novel Arrhythmia Detection Algorithm
- ClinicalTrials.gov ID
- NCT04981496
- Acronym / sponsor ID
- 20HH5882
- Conditions
- ICD, Implantable Defibrillator User, Cardiomyopathies
- Keywords
- ICD, arrhythmia, algorithm, haemodynamic sensor, bipolar electrogram
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulated Arrhythmias | – | Other: Observational Study during Clinical and Simulated arrhythmias in patients with ICDsSimulate 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 | – | Other: Observational Study during Clinical and Simulated arrhythmias in patients with ICDsGenuine clinical VT (acute presentation), RV lead fracture/noise or sinus tachycardia on exercise whilst recording haemodynamics and a surface bipolar electrogram. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- Study A and B
- Patients referred for conventional defibrillator implantation or generator change.
- Adults (age > 18 years)
- Willing to take part and able to give consent.
- Study C
Key exclusion criteria (16 listed)
- Unable to give consent.
- Children (age < 18 years)
- Pregnant women.
- Intracardiac thrombus
- AF without regular anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Study during Clinical and Simulated arrhythmias in patients with ICDsObservational Study during Clinical and Simulated arrhythmias in patients with ICDs | Other | Clinical Arrhythmias, Simulated Arrhythmias |
Primary outcome
Outperforming current arrhythmia detection algorithms
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: Undecided
Related trials for ICD
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
RecruitingObservational study
BIO|STREAM.CSP Study
Cardiac Pacing, Cardiac Pacemaker
Recruiting
HeartLogic™ in Patients With Heart Failure.
Heart Failure
RecruitingObservational study
Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients
Atrial Fibrillation, Pacemaker Ddd
Recruiting
Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease
Parkinson Disease, Impulse Control Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ICD and Implantable Defibrillator User, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outperforming current arrhythmia detection algorithms (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.