Cryoballoon Atrial Fibrillation Ablation Registry

Conditions

Atrial Fibrillation

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.

P. Yu. Zubkova, T Lubimceva, А Г Топчян, К. V. Davtyan, E Artiykhina et al. (15 authors)

European Heart Journal2020-11-01

10.1093/ehjci/ehaa946.3367

Real life experience with atrial fibrillation cryoballoon ablation: results from a nationwide registry

T Lubimceva, A. G. Topchyan, К. V. Davtyan, E Artiykhina, E Tarasiyk et al. (15 authors)

European Heart Journal2020-11-01

10.1093/ehjci/ehaa946.0618

P1422Low incidence of major procedure-related adverse events of cryoballoon ablation in real practice: an interim analysis of the Russian national prospective cryoablation registry

T Lubimceva, A. G. Topchyan, К. V. Davtyan, Y A Poleschenko, E Artiykhina et al. (15 authors)

EP Europace2020-06-011 citations

10.1093/europace/euaa162.329

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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 antiarrhythmic drug treatment at 12 months	1 Year	—

Countries

Russia

Outcome results