AF Ablation With the Ablation Index

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

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Catheter ablation

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 Type: Observational
• Enrollment (Actual): 450

Contacts and Locations

• Study Contact: Name: Evgeny Mikhaylov, MD, PhD; Phone Number: 007(812)702-51-64; Email: e.mikhaylov@almazovcentre.ru
• Study Contact Backup: Name: Svetlana Gar'kina, MD; Phone Number: 007(812)702-51-64

Study Locations

• Russian Federation
  • Saint-Petersburg, Russian Federation, 197341
    • Federal State Budgetary Institution "V. A. Almazov Federal North-West Medical Research Centre" of the Ministry of Health of the Russian Federation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients (both males and females aged 18-79 years) with indications to atrial fibrillation ablation undergoing radiofrequency catheter pulmonary vein isolation

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Presence of contraindications to AF ablation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Procedure time	Duration of the total ablation procedure and fluoroscopy needed to complete pulmonary vein isolation, expressed in minutes.	180 minutes
Fluoroscopy time	Fluoroscopy duration within the procedure	24 hours
Electrical reconduction	Number of participats with electrical reconduction into pulmonary veins as assessed during repeat procedures.	2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: AF0718NR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No