Heart DiseasesNCT03947021
Developing Methods for Reconstructing Electrical Heart Activity
A study testing Computed tomography (CT) scan and Body-surface potential mapping in people with Heart Diseases and Cardiac Conduction Defect, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Non-invasive reconstruction of electrical heart activity can yield important scientific and clinical insights in cardiac rhythm disorders. In this study, The investigators aim at developing methods for reconstructing electrical heart activity non-invasively, and to use these methods to investigate cardiac rhythm… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases, Cardiac Conduction Defect
- What is being tested?
- Computed tomography (CT) scan and Body-surface potential mapping
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2012to Mar 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Known strong reaction against electrode attachment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing Mathematical Methods for Non-invasive Reconstruction of Electrical Heart Activity From Body-surface Electrocardiograms and a CT-based Torso-heart Geometry
Non-invasive reconstruction of electrical heart activity can yield important scientific and clinical insights in cardiac rhythm disorders. In this study, The investigators aim at developing methods for reconstructing electrical heart activity non-invasively, and to use these methods to investigate cardiac rhythm disorders to answer clinical and scientific questions.
- Conditions
- Heart Diseases, Cardiac Conduction Defect
- Being tested
- Computed tomography (CT) scan, Body-surface potential mapping
- Keywords
- Electrocardiography, Body Surface Potential Mapping, Computational Biology
- Medical subject headings
- Heart Diseases, Cardiac Conduction System Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomography (CT) scanRadiation
A CT scan of thorax and heart will be performed in the CT+BSPM group.
Body-surface potential mappingDevice
Measurement of 256-lead body-surface electrocardiogram
| Study group | Role | What they receive |
|---|---|---|
| BSPM-only group | Experimental | Participants will only receive body-surface potential mapping (BSPM) with an extensive electrode set (256 electrodes). Receives: Device: Body-surface potential mapping |
| CT+BSPM group | Experimental | Participants will receive body-surface potential measurements (BSPM) and a CT scan. These data will allow for non-invasive reconstruction of electrical potentials at the heart surface. Receives: Radiation: Computed tomography (CT) scan; Device: Body-surface potential mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epicardial potentials
Primary outcome data include reconstructed electrical heart activity such as:
- epicardial potentials (units: millivolts [mV])
These outcome data are obtained at the moment of inclusion.
The primary outcome measures are a comparison of the primary outcome data with invasive outcome data available from clinical records:
- Reconstructed epicardial potentials (mV) will be compared to selected invasive epicardial potentials (mV) obtained from catheter-based recordings or pacemaker-based recordings available as clinical data
Measured: Day one, direct measurement
Epicardial electrograms
Primary outcome data include reconstructed electrical heart activity such as:
- epicardial electrograms (units: millivolts [mV] over milliseconds [ms])
These outcome data are obtained at the moment of inclusion.
The primary outcome measures are a comparison of the primary outcome data with invasive outcome data available from clinical records:
- Reconstructed electrograms (mV) will be compared to selected invasive epicardial electrograms (mV) obtained from catheter-based recordings or pacemaker-based recordings available as clinical data
Measured: Day one, direct measurement
Epicardial activation and recovery sequences
Primary outcome data include reconstructed electrical heart activity such as:
- epicardial activation and recovery isochrones (units: milliseconds [ms])
These outcome data are obtained at the moment of inclusion.
The primary outcome measures are a comparison of the primary outcome data with invasive outcome data available from clinical records:
- Reconstructed activation and recovery sequences (ms) will be compared to recorded catheter-based sequences from clinical data (ms).
Measured: Day one, direct measurement
Secondary outcomes (1)
Disease-specific differences in primary outcome measures
The secondary study endpoints include disease-specific differences of the primary outcome measures, which may include abnormal (low-amplitude, fractionated) electrograms and abnormal activation and recovery sequences. Depending on the primary measure, these differences will be expressed in absolute units (mV, ms) or relative differences (%).
Measured: Day one, direct measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study startJan 2012
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947021
- Sponsor's protocol ID
- METC 11-2-043
- Other IDs
- NHS 2007T51
- Status last verified
- Sep 2021
- First submitted
- 21 Nov 2012
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Mathematical Methods for Non-invasive Reconstruction of Electrical Heart Activity From Body-surface Electrocardiograms and a CT-based Torso-heart Geometry
- ClinicalTrials.gov ID
- NCT03947021
- Acronym / sponsor ID
- METC 11-2-043
- Conditions
- Heart Diseases, Cardiac Conduction Defect
- Keywords
- Electrocardiography, Body Surface Potential Mapping, Computational Biology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 13 May 2019 (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.
Non-invasive reconstruction of electrical heart activity can yield important scientific and clinical insights in cardiac rhythm disorders. In this study, The investigators aim at developing methods for reconstructing electrical heart activity non-invasively, and to use these methods to investigate cardiac rhythm disorders to answer clinical and scientific questions.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BSPM-only group | Experimental | Device: Body-surface potential mappingParticipants will only receive body-surface potential mapping (BSPM) with an extensive electrode set (256 electrodes). |
| CT+BSPM group | Experimental | Radiation: Computed tomography (CT) scan, Device: Body-surface potential mappingParticipants will receive body-surface potential measurements (BSPM) and a CT scan. These data will allow for non-invasive reconstruction of electrical potentials at the heart surface. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Known strong reaction against electrode attachment
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 |
|---|---|---|
| Computed tomography (CT) scanA CT scan of thorax and heart will be performed in the CT+BSPM group. | Radiation | CT+BSPM group |
| Body-surface potential mappingMeasurement of 256-lead body-surface electrocardiogram | Device | BSPM-only group, CT+BSPM group |
Primary outcome
Epicardial potentials
Time frame: Day one, direct measurement
Primary outcome data include reconstructed electrical heart activity such as: - epicardial potentials (units: millivolts [mV]) These outcome data are obtained at the moment of inclusion. The primary outcome measures are a comparison of the primary outcome data with invasive outcome data available from clinical records: - Reconstructed epicardial potentials (mV) will be compared to selected invasive epicardial potentials (mV) obtained from catheter-based recordings or pacemaker-based recordings available as clinical data
Epicardial electrograms
Time frame: Day one, direct measurement
Primary outcome data include reconstructed electrical heart activity such as: - epicardial electrograms (units: millivolts [mV] over milliseconds [ms]) These outcome data are obtained at the moment of inclusion. The primary outcome measures are a comparison of the primary outcome data with invasive outcome data available from clinical records: - Reconstructed electrograms (mV) will be compared to selected invasive epicardial electrograms (mV) obtained from catheter-based recordings or pacemaker-based recordings available as clinical data
Epicardial activation and recovery sequences
Time frame: Day one, direct measurement
Primary outcome data include reconstructed electrical heart activity such as: - epicardial activation and recovery isochrones (units: milliseconds [ms]) These outcome data are obtained at the moment of inclusion. The primary outcome measures are a comparison of the primary outcome data with invasive outcome data available from clinical records: - Reconstructed activation and recovery sequences (ms) will be compared to recorded catheter-based sequences from clinical data (ms).
1 secondary outcome
Disease-specific differences in primary outcome measures
Time frame: Day one, direct measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
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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.
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?
A study testing Computed tomography (CT) scan and Body-surface potential mapping in people with Heart Diseases and Cardiac Conduction Defect, run by Maastricht University Medical Center at 1 site in Netherlands.
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 0 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 8 Sep 2021. 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 Netherlands. 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?
Epicardial potentials (time frame: Day one, direct measurement). The study lists 3 primary outcomes in all. 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 8 Sep 2021.