Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05714800
Status:
RECRUITING
Last Update Posted:
2023-11-08
First Post:
2023-01-22
Brief Title:
Endocardial Mapping of Left Atrium for Evaluation of Concomitant Surgical Ablation Lesions
Sponsor:
University Medical Centre Ljubljana
Organization:
University Medical Centre Ljubljana
Study Overview
Official Title:
Endocardial Mapping of Left Atrium for Evaluation of Concomitant Surgical Ablation Lesions for Treatment of Atrial Fibrillation
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLAN-AF
Brief Summary:
Concomitant ablation is an effective treatment for patients with various types of atrial fibrillation undergoing heart surgery
However recurrences of tachycardias after concomitant ablation can happen and seem to be mostly related to reentry mechanism resulting in atrial tachycardias
The aim of the study is to perform invasive re-mapping of ablated regions in the atria to assess durability of ablation lesions and prevalence of conduction gaps that can be targets for additional ablation to lower longterm arrhythmia recurrence
However recurrences of tachycardias after concomitant ablation can happen and seem to be mostly related to reentry mechanism resulting in atrial tachycardias
The aim of the study is to perform invasive re-mapping of ablated regions in the atria to assess durability of ablation lesions and prevalence of conduction gaps that can be targets for additional ablation to lower longterm arrhythmia recurrence
Detailed Description:
Patients after concomitant ablation for treatment of atrial fibrillation will be enrolled At ablation procedure pulmonary veins will be isolated and additional ablation lines will be performed in the left atrium posterior wall box lesion connecting lesion to the mitral annulus connecting lesion to the left atrial appendage and the right atrium intercaval connecting lesion cavotricuspid isthmus lesion and left atrial appendage will be excluded suture and excision clipping device at the discretion and expertise of the operator Radiofrequency andor cryoablation will be used at the discretion and expertise of the operator
Invasive mapping with a high density mapping catheter connected to a three-dimensional electro-anatomical mapping system will be performed to assess pulmonary vein isolation and linear lesion durability 3 months after the initial concomitant ablation Potential gaps will be identified and ablated with a radiofrequency ablation catheter
Participants will be followed-up clinically and with holter ECG before and after the invasive re-mapping procedure up to the first year after the concomitant ablation procedure
Invasive mapping with a high density mapping catheter connected to a three-dimensional electro-anatomical mapping system will be performed to assess pulmonary vein isolation and linear lesion durability 3 months after the initial concomitant ablation Potential gaps will be identified and ablated with a radiofrequency ablation catheter
Participants will be followed-up clinically and with holter ECG before and after the invasive re-mapping procedure up to the first year after the concomitant ablation procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None