CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Creating an electro-anatomical mapother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05812261
NCT05812261N/ACompleted

Lesion Characteristics After Pulsed-Field Ablation in Patients With Atrial Fibrillation and a Left Common Ostium

Onze Lieve Vrouwe Gasthuis·observational·Posted Apr 13, 2023·Updated Mar 6, 2024

In Brief

An observational study evaluating Creating an electro-anatomical map for Atrial Fibrillation and 2 related conditions. Completed, enrolled 24 participants across 1 site.

Detailed Summary

This study aims to investigate the lesion characteristics after pulmonary vein isolation using pulsed-field ablation in patients with atrial fibrillation and a common of the left pulmonary veins. The main question it aims to answer is: In which percentage of the patients will pulsed field ablation result in successful isolation of the left common ostium? Nineteen patients will be prospectively included in OLVG. All patients will be treated with pulsed-field ablation (routine care). After the ablation procedure, an electro-anatomical map will be created using the ablation catheter and a mapping system. This map will display the left atrium and the lesion in detail. After the procedure, three experienced operators are asked to draw a line around the LCO in the anatomical map where they would have ablated if conventional radiofrequency ablation was used. The distance between the drawn line and the ablation lesion will be measured at three predefined points. The lesion is considered successful if the mean distance is within ±10mm at all measurement points.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands
CollaboratorsOLVG

Timeline

N/ACompletedFinished
202420252026
First PostedApr 13, 2023
Enrollment StartJul 19, 2023
Primary CompletionFeb 29, 2024
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 3.2 years ago

Interventions

Creating an electro-anatomical mapother

After the routine pulsed-field ablation procedure, the operator will create an electro-anatomical map using the ablation catheter and a 3D mapping system.