Cryoballoon Atrial Fibrillation Ablation Registry

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT03040037
• Lead Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Brief Summary

This is a prospective registry of atrial fibrillation cryoablation in the Russian Federation. This study is observational, prospective, multicenter, open-label

Detailed Description

The purpose of this Registry is to describe characteristics of patients undergoing cryoballoon ablation, diversity of cryoablation techniques among different centers; to evaluate efficacy and safety of the procedure in the centers with different levels of experience.

Study Timeline

• Study First Submitted: 2016-12-05
• Study Start: 2017-01-01
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-01
• Primary Completion: 2021-07-01
• Status Verified: 2022-03
• Study Completion: 2022-03-21
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

• The indications for catheter ablation of atrial fibrillation
• Signed informed consent to participate in the Register
• Patients undergoing cryoballoon ablation

Exclusion Criteria

• Left atrial thrombosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from arrhythmia: Number of participants with no evidence of atrial achyarrhythmia longer than 30 s, as detected by regular ECG monitoring	1 Year	ECG monitoring will be performed in accordance with sites' routine practices (Holter monitoring every 3 months, implantable loop recorder, cardiac rhythm management device interrogation, other regular ECG screening)

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events that are related to underlying disease (cardiovascular events not related to atrial fibrillation cryoablation)	1 Year
Atrial fibrillation procedure characteristics: Mean total ablation procedure time in minutes, mean fluoroscopy time in minutes (during the ablation procedure)	Above parameters will be assessed only during the procedure of cryoablation	Data will be collected using a web-based system of electronic case report forms
Number of participants with adverse events that are related to treatment (i.e. cardiac tamponade, periprocedural stroke, pulmonary vein stenosis, esophageal damage, etc)	1 Year
Number of participants with antiarrhythmic drug treatment at 12 months	1 Year

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