Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-28 @ 6:51 PM
Study NCT ID:
NCT03634592
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2018-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AF Ablation With the Ablation Index
Sponsor:
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Organization:
Study Overview
Official Title:
A Prospective Registry of Atrial Fibrillation Ablation Using the Prediction of Lesion Depth Technology
Status:
COMPLETED
Status Verified Date:
2024-03
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:
None
Brief Summary:
This is an observational multicenter registry of atrial fibrillation catheter ablation performed using the ablation index technology.
Detailed Description:
This is an observational multicenter registry of atrial fibrillation catheter ablation performed using the ablation index technology, which has been introduced as a tool predicting ablation lesion depth. The index incorporates the following characteristics of radiofrequency point-by-point ablation: radiofrequency energy power, contact force, duration of ablation. Since the ablation index is calculated for every individual operator depending on his(her) personal skills, there is no a strict indication on the safe and effective range of the index. This registry aims to evaluate ablation index values used in different centers by different operators. Prospective information on arrhythmia recurrence rate and type, characteristics of redo ablations, characteristics of reconduction ablated areas will be gathered.
Study Oversight
Has Oversight DMC:
False
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?: