Atrial RemodelingCLASS-VANCT06425822
Characterization of Left Atrial Substrate in Patients With Ventricular Arrhythmias
An observational study of Atrial Remodeling, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The goal of this observational study is to analyze the characteristics of left atrial electroanatomical maps in patients without a history of atrial fibrillation but with a high clinical risk of developing it, as indicated by the presence of structural heart disease or a CHA2DS2-VASc score ≥ 2 points. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Remodeling
- What is being tested?
- Left atrial electroanatomical mapping
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Nov 2023to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients undergoing ventricular arrhythmias ablations in whom transeptal access is needed for the ablation of the targeted arrhythmia.
Who may be able to join
- Absence of a prior history of atrial fibrillation or flutter.
- Patients presenting for ablation of any ventricular tachycardia related to structural heart disease or any ventricular arrhythmia with a CHA2DS2-VASc score ≥ 2.
Who cannot join
- Presence of thrombus in the left atrial appendage.
- Complications related to the index procedure.
- Insufficient quality of the left atrial electroanatomical map.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, 1090
Andrea Sarkozy, MD, PhD, 0032 02476 3657, Andrea.Sarkozy@uzbrussel.be
About this study
The goal of this observational study is to analyze the characteristics of left atrial electroanatomical maps in patients without a history of atrial fibrillation but with a high clinical risk of developing it, as indicated by the presence of structural heart disease or a CHA2DS2-VASc score ≥ 2 points. The study cohort will be compared to a historical cohort of patients with diagnosed atrial fibrillation in a propensity-matched fashion.
The main questions it aims to answer are:
- Are the left atrial electroanatomical changes a consequence or a precursor to the development of atrial fibrillation?
- Are the left atrial electroanatomical findings different between patients with atrial fibrillation and those at high risk of developing it?
- What is the prognostic impact of left atrial pathologic changes in patients without diagnosed atrial fibrillation in terms of cardiovascular outcomes?
- Conditions
- Atrial Remodeling
- Being tested
- Left atrial electroanatomical mapping
- Medical subject headings
- Atrial Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left atrial electroanatomical mappingDiagnostic test
Left atrial electroanatomical mapping (substrate and functional mapping)
| Study group | Role | What they receive |
|---|---|---|
| Left atrial mapping group in patients without atrial fibrillation | Inclusion criteria:
* Age ≥ 18 years old.
* Absence of a prior history of atrial fibrillation or flutter.
* Patients presenting for ablation of any ventricular tachycardia related to structural heart disease or any ventricular arrhythmia with a CHA2DS2-VASc score ≥ 2.
Exclusion criteria:
* Presence of thrombus in the left atrial appendage.
* Complications related to the index procedure.
* Insufficient quality of the left atrial electroanatomical map. Receives: Diagnostic Test: Left atrial electroanatomical mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substrate characterization of the left atrium.
Substrate characterization will involve measuring Low Voltage (LV) and Transition Voltage (TV) Zones (LV zone voltage cut-off of <0.5mV; TV zone voltage limits within 0.5 and 1mV). These zones will be considered if they encompass an area of at least 1cm², containing ≥3 neighboring points within ≤10mm distance. The total LVZ and TVZ surfaces will be expressed as a percentage relative to the total surface area of the left atrium (excluding the pulmonary veins and the mitral annulus).
A comparative analysis of substrate characteristics will be conducted between two groups: the study group (comprising patients without atrial fibrillation but at risk of developing it) and the control group (a historical cohort of patients with known atrial fibrillation).
Measured: 18 months
Functional characterization of the left atrium.
Functional analysis will rely on identifying deceleration zones characterized by isochronal crowding, defined as having ≥3 isochrones within a 1cm radius, using an 8-color scale of left atrial isochronal activation mapping.
A comparative analysis of functional characteristics will be conducted between two groups: the study group (comprising patients without atrial fibrillation but at risk of developing it) and the control group (a historical cohort of patients with known atrial fibrillation).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start8 Nov 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial RemodelingStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Sarkozy, Universitair Ziekenhuis Brussel
- Investigators
- Andrea Sarkozy, MD, PhD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425822
- Sponsor's protocol ID
- EC-2023-281
- Acronym
- CLASS-VA
- Status last verified
- May 2024
- First submitted
- 9 May 2024
- Last updated
- 22 May 2024
- Results posted
- 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 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Left Atrial Substrate in Patients With Ventricular Arrhythmias
- ClinicalTrials.gov ID
- NCT06425822
- Acronym / sponsor ID
- CLASS-VA / EC-2023-281
- Conditions
- Atrial Remodeling
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 22 May 2024 (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.
The goal of this observational study is to analyze the characteristics of left atrial electroanatomical maps in patients without a history of atrial fibrillation but with a high clinical risk of developing it, as indicated by the presence of structural heart disease or a CHA2DS2-VASc score ≥ 2 points. The study cohort will be compared to a historical cohort of patients with diagnosed atrial fibrillation in a propensity-matched fashion.
The main questions it aims to answer are:
- Are the left atrial electroanatomical changes a consequence or a precursor to the development of atrial fibrillation?
- Are the left atrial electroanatomical findings different between patients with atrial fibrillation and those at high risk of developing it?
- What is the prognostic impact of left atrial pathologic changes in patients without diagnosed atrial fibrillation in terms of cardiovascular outcomes?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Left atrial mapping group in patients without atrial fibrillation | – | Diagnostic Test: Left atrial electroanatomical mappingInclusion criteria: * Age ≥ 18 years old. * Absence of a prior history of atrial fibrillation or flutter. * Patients presenting for ablation of any ventricular tachycardia related to structural heart disease or any ventricular arrhythmia with a CHA2DS2-VASc score ≥ 2. Exclusion criteria: * Presence of thrombus in the left atrial appendage. * Complications related to the index procedure. * Insufficient quality of the left atrial electroanatomical map. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing ventricular arrhythmias ablations in whom transeptal access is needed for the ablation of the targeted arrhythmia.
Key inclusion criteria (2 listed)
- Absence of a prior history of atrial fibrillation or flutter.
- Patients presenting for ablation of any ventricular tachycardia related to structural heart disease or any ventricular arrhythmia with a CHA2DS2-VASc score ≥ 2.
Key exclusion criteria (3 listed)
- Presence of thrombus in the left atrial appendage.
- Complications related to the index procedure.
- Insufficient quality of the left atrial electroanatomical map.
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 |
|---|---|---|
| Left atrial electroanatomical mappingLeft atrial electroanatomical mapping (substrate and functional mapping) | Diagnostic test | Left atrial mapping group in patients without atrial fibrillation |
Primary outcome
Substrate characterization of the left atrium.
Time frame: 18 months
Substrate characterization will involve measuring Low Voltage (LV) and Transition Voltage (TV) Zones (LV zone voltage cut-off of <0.5mV; TV zone voltage limits within 0.5 and 1mV). These zones will be considered if they encompass an area of at least 1cm², containing ≥3 neighboring points within ≤10mm distance. The total LVZ and TVZ surfaces will be expressed as a percentage relative to the total surface area of the left atrium (excluding the pulmonary veins and the mitral annulus). A comparative analysis of substrate characteristics will be conducted between two groups: the study group (comprising patients without atrial fibrillation but at risk of developing it) and the control group (a historical cohort of patients with known atrial fibrillation).
Functional characterization of the left atrium.
Time frame: 18 months
Functional analysis will rely on identifying deceleration zones characterized by isochronal crowding, defined as having ≥3 isochrones within a 1cm radius, using an 8-color scale of left atrial isochronal activation mapping. A comparative analysis of functional characteristics will be conducted between two groups: the study group (comprising patients without atrial fibrillation but at risk of developing it) and the control group (a historical cohort of patients with known atrial fibrillation).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Remodeling
Enrolling by invitation
Atrial Remodeling After PFA Substrate Modification for Persistent AF (PeAF)
Persistent Atrial Fibrillation, Atrial Fibrillation (AF)
Not yet recruiting
Dapagliflozin and Right Heart Recovery After ASD Device Closure
ASD2(Secundum Atrial Septal Defect)
RecruitingPhase 2
Finerenone After Catheter Ablation to Reduce Atrial Fibrillation Recurrence
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Not yet recruitingPhase 4
Ezetimibe for Arrhythmia Recurrence After AF Ablation
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Radiofrequency and Cryoablation of the Posterior Wall of the Left Atrium
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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.
Andrea Sarkozy, MD, PhD principal investigator
Universitair Ziekenhuis Brussel
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 Atrial Remodeling, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 3 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: looking for participants now, as of the sponsor's last update on 22 May 2024. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Sarkozy, MD, PhD (0032 02476 3657, Andrea.Sarkozy@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substrate characterization of the left atrium. (time frame: 18 months). The study lists 2 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 22 May 2024.