Characterization of Left Atrial Substrate in Patients With Ventricular Arrhythmias

NCT ID: NCT06425822

Last Updated: 2024-05-22

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-08

Study Completion Date

2027-10-31

Brief Summary

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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?

Detailed Description

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Conditions

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Atrial Remodeling

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Left atrial electroanatomical mapping

Intervention Type DIAGNOSTIC_TEST

Left atrial electroanatomical mapping (substrate and functional mapping)

Interventions

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Left atrial electroanatomical mapping

Left atrial electroanatomical mapping (substrate and functional mapping)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Andrea Sarkozy

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Sarkozy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

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Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Andrea Sarkozy, MD, PhD

Role: CONTACT

0032 02476 3657

Facility Contacts

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Andrea Sarkozy, MD, PhD

Role: primary

0032 02476 3657

Other Identifiers

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EC-2023-281

Identifier Type: -

Identifier Source: org_study_id

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