Cardiac ArrhythmiaSIGILNCT05508880
SIGIL: Signal Interpretation and Analysis In Real Life Cardiac Arrhythmias
An observational study of Cardiac Arrhythmia, run by National Heart Centre Singapore at 1 site in Singapore.
Trial summary
This study essentially consists of the prospective collection of mapping data derived from patients undergoing clinically indicated 3D mapping procedures. There is no intervention. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrhythmia
- How many people
- 80 participants
- Where
- 1 siteSingapore
- Study dates
- 30 Oct 2019to 30 May 2023
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: At the National Heart Center Singapore, based on national audit data specific for NHCS, approximately 600 ablation procedures are performed per year, of which at least 150 would be expected to suitable for study inclusion. To recruit 40, we would only require ~25% participation rate which we think is realistic.
Who may be able to join
- Patient undergoing a clinically indicated 3D mapping procedure for a cardiac arrhythmia
- Ability to provide informed consent
Who cannot join
- Patients who cannot provide informed consent will be excluded. Otherwise, there are no specific exclusion criteria.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National Heart Centre Singapore
Singapore, 169609
Luh Nah Lum, 67042265, lum.luh.nah@nhcs.com.sg
Eric Lim, MBBS
About this study
This study essentially consists of the prospective collection of mapping data derived from patients undergoing clinically indicated 3D mapping procedures. There is no intervention. The mapping data is used to construct and/or validate new activation mapping algorithms but will not be used to direct clinical treatment of the patient.
Read the detailed description
Cardiac arrhythmias are a common clinical problem in cardiology. Often, such arrhythmias can be effectively and permanently treated through catheter ablation.
A key technology enabling the success of catheter ablation is activation mapping of cardiac arrhythmias. This refers to the construction of maps which depict the sequential activation of the cardiac chamber of interest. It is a fundamental electrophysiology technique, but at the same time, the principles behind activation map construction have not changed for decades.
In brief, the way activation maps are constructed nowadays consists of the following steps:
(i) Sequential acquisition of voltage signals throughout the cardiac chamber of interest, recording both the signal together with the location of the signal in 3D space (ii) Local activation time annotation of each of the acquired signals in relation to a so-called timing reference (iii) Depiction of the annotated activation time graphically as a so-called activation map, through which the mechanism of the arrhythmia can be understood and an appropriate ablation target chosen
Following assignment of the LAT to each individual signal, the map is complete and can be used to discern the arrhythmia circuit to choose an appropriate ablation target.
The objective of this study is to develop, refine and validate LAT-independent methods of activation map analysis using mapping data acquired from patients undergoing clinically indicated EP mapping and ablation procedures.
Specific objectives:
(i) Electrogram signature analysis. To use machine learning techniques to identify electrogram properties associated with specific conduction patterns.
(ii) Intracardiac EGM summation. To integrate all acquired points into a global function that allows as precise a determination as possible of the period of isthmus conduction in re-entrant arrhythmias.
(iii) Conduction velocity estimation. To algorithmically determine conduction velocity using proprietary techniques to wholly or partially reduce reliance on LAT annotation.This study aims to collect the electroanatomic 3D maps from patients to develop novel mapping algorithms, but this map data is not used to direct clinical treatment.
- Conditions
- Cardiac Arrhythmia
- Medical subject headings
- Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall objective of this study is to develop, refine and validate LAT-independent methods of activation map analysis using mapping data acquired from patients undergoing clinicallyindicated EP mapping and ablation procedures.
This study aims to collect the electroanatomic 3D maps from patients to develop novel mapping algorithms, but this map data is not used to direct clinical treatment.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start30 Oct 2019
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508880
- Sponsor's protocol ID
- 2019/2774
- Acronym
- SIGIL
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIGIL: Signal Interpretation and Analysis In Real Life Cardiac Arrhythmias
- ClinicalTrials.gov ID
- NCT05508880
- Acronym / sponsor ID
- SIGIL / 2019/2774
- Conditions
- Cardiac Arrhythmia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 19 Aug 2022 (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.
This study essentially consists of the prospective collection of mapping data derived from patients undergoing clinically indicated 3D mapping procedures. There is no intervention. The mapping data is used to construct and/or validate new activation mapping algorithms but will not be used to direct clinical treatment of the patient.
Detailed description
Cardiac arrhythmias are a common clinical problem in cardiology. Often, such arrhythmias can be effectively and permanently treated through catheter ablation.
A key technology enabling the success of catheter ablation is activation mapping of cardiac arrhythmias. This refers to the construction of maps which depict the sequential activation of the cardiac chamber of interest. It is a fundamental electrophysiology technique, but at the same time, the principles behind activation map construction have not changed for decades.
In brief, the way activation maps are constructed nowadays consists of the following steps:
(i) Sequential acquisition of voltage signals throughout the cardiac chamber of interest, recording both the signal together with the location of the signal in 3D space (ii) Local activation time annotation of each of the acquired signals in relation to a so-called timing reference (iii) Depiction of the annotated activation time graphically as a so-called activation map, through which the mechanism of the arrhythmia can be understood and an appropriate ablation target chosen
Following assignment of the LAT to each individual signal, the map is complete and can be used to discern the arrhythmia circuit to choose an appropriate ablation target.
The objective of this study is to develop, refine and validate LAT-independent methods of activation map analysis using mapping data acquired from patients undergoing clinically indicated EP mapping and ablation procedures.
Specific objectives:
(i) Electrogram signature analysis. To use machine learning techniques to identify electrogram properties associated with specific conduction patterns.
(ii) Intracardiac EGM summation. To integrate all acquired points into a global function that allows as precise a determination as possible of the period of isthmus conduction in re-entrant arrhythmias.
(iii) Conduction velocity estimation. To algorithmically determine conduction velocity using proprietary techniques to wholly or partially reduce reliance on LAT annotation.This study aims to collect the electroanatomic 3D maps from patients to develop novel mapping algorithms, but this map data is not used to direct clinical treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- At the National Heart Center Singapore, based on national audit data specific for NHCS, approximately 600 ablation procedures are performed per year, of which at least 150 would be expected to suitable for study inclusion. To recruit 40, we would only require ~25% participation rate which we think is realistic.
Key inclusion criteria (2 listed)
- Patient undergoing a clinically indicated 3D mapping procedure for a cardiac arrhythmia
- Ability to provide informed consent
Key exclusion criteria (1 listed)
- Patients who cannot provide informed consent will be excluded. Otherwise, there are no specific exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The overall objective of this study is to develop, refine and validate LAT-independent methods of activation map analysis using mapping data acquired from patients undergoing clinicallyindicated EP mapping and ablation procedures.
Time frame: 2 years
This study aims to collect the electroanatomic 3D maps from patients to develop novel mapping algorithms, but this map data is not used to direct clinical treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Individual participant dataSharing planned: No
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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.
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 Cardiac Arrhythmia, run by National Heart Centre Singapore at 1 site in Singapore.
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 2 inclusion and 1 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 19 Aug 2022. 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 Singapore. 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?
Contact Lum Luh Nah (6704 2265, lum.luh.nah@nhcs.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall objective of this study is to develop, refine and validate LAT-independent methods of activation map analysis using mapping data acquired from patients undergoing clinicallyindicated EP mapping and ablation procedures. (time frame: 2 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 19 Aug 2022.