AF Ablation With the Ablation Index

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT03634592
• Lead Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

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 Timeline

• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2018-08-15
• Study First Posted: 2018-08-16
• Study Start: 2019-10-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• indications for catheter ablation of atrial fibrillation;
• signed informed consent

Exclusion Criteria

• Presence of contraindications to AF ablation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from atrial fibrillation	1 year	Number of participants with no evidence of atrial tachyarrhythmia longer than 30 s in duration at 12 months after ablation, as detected by regular ECG monitoring according to centres' established practices (Holter monitoring every 3 months, implantable loop recorder, cardiac rhythm management device interrogation, other regular ECG screening). Data will be collected using a web-based system with electronic case report forms.

Secondary Outcome Measures

Name	Time	Method
Fluoroscopy time	24 hours	Fluoroscopy duration within the procedure
Acute complications	30 days	Number of participants with adverse events that are related to treatment (i.e. cardiac tamponade, periprocedural stroke, pulmonary vein stenosis, esophageal damage, etc) whithin 30 days after ablation. Data will be collected using a web-based system with electronic case report forms.
Procedure time	180 minutes	Duration of the total ablation procedure and fluoroscopy needed to complete pulmonary vein isolation, expressed in minutes.
Electrical reconduction	2 years	Number of participats with electrical reconduction into pulmonary veins as assessed during repeat procedures.

Trial Locations

Locations (1)

Federal State Budgetary Institution "V. A. Almazov Federal North-West Medical Research Centre" of the Ministry of Health of the Russian Federation; 🇷🇺 Saint-Petersburg, Russian Federation