Cryoballoon Atrial Fibrillation Ablation Registry

Atrial Fibrillation Clinical Trial

Official title:

Prospective Registry of Atrial Fibrillation Cryoballoon Ablation in the Russian Federation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03040037
• Other study ID #: PRAF-CA
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: March 21, 2022

Study information

• Verified date: March 2022
• 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 [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: March 21, 2022
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

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 (2)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from arrhythmia: Number of participants with no evidence of atrial achyarrhythmia longer than 30 s, as detected by regular ECG monitoring	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)	1 Year
Secondary	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
Secondary	Number of participants with adverse events that are related to underlying disease (cardiovascular events not related to atrial fibrillation cryoablation)		1 Year
Secondary	Atrial fibrillation procedure characteristics: Mean total ablation procedure time in minutes, mean fluoroscopy time in minutes (during the ablation procedure)	Data will be collected using a web-based system of electronic case report forms	Above parameters will be assessed only during the procedure of cryoablation
Secondary	Number of participants with antiarrhythmic drug treatment at 12 months		1 Year