AF Ablation With the Ablation Index

Atrial Fibrillation Clinical Trial

Official title:

A Prospective Registry of Atrial Fibrillation Ablation Using the Prediction of Lesion Depth Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634592
• Other study ID #: AF0718NR
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational multicenter registry of atrial fibrillation catheter ablation performed using the ablation index technology.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Presence of contraindications to AF ablation

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Catheter ablation
Radiofrequency catheter pulmonary vein isolation

Locations

Country	Name	City	State
Russian Federation	Federal State Budgetary Institution "V. A. Almazov Federal North-West Medical Research Centre" of the Ministry of Health of the Russian Federation	Saint-Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from atrial fibrillation	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.	1 year
Secondary	Acute complications	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.	30 days
Secondary	Procedure time	Duration of the total ablation procedure and fluoroscopy needed to complete pulmonary vein isolation, expressed in minutes.	180 minutes
Secondary	Fluoroscopy time	Fluoroscopy duration within the procedure	24 hours
Secondary	Electrical reconduction	Number of participats with electrical reconduction into pulmonary veins as assessed during repeat procedures.	2 years