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Completed

NCT Number: NCT03040037

Cryoballoon Atrial Fibrillation Ablation Registry

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Saint Petersburg, 197341, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Freedom from arrhythmia: Number of participants with no evidence of atrial achyarrhythmia longer than 30 s, as detected by regular ECG monitoring

    Time frame: 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 outcomes

  1. Number of participants with adverse events that are related to treatment (i.e. cardiac tamponade, periprocedural stroke, pulmonary vein stenosis, esophageal damage, etc)

    Time frame: 1 Year

  2. Number of participants with adverse events that are related to underlying disease (cardiovascular events not related to atrial fibrillation cryoablation)

    Time frame: 1 Year

  3. Atrial fibrillation procedure characteristics: Mean total ablation procedure time in minutes, mean fluoroscopy time in minutes (during the ablation procedure)

    Time frame: 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

  4. Number of participants with antiarrhythmic drug treatment at 12 months

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • RUSSIAN SOCIETY OF CARDIOLOGY

Registry information

Official study title

Prospective Registry of Atrial Fibrillation Cryoballoon Ablation in the Russian Federation

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Feb 1, 2017
Registry last updated
Apr 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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