Cryoballoon Atrial Fibrillation Ablation Registry

Prospective Registry of Atrial Fibrillation Cryoballoon Ablation in the Russian Federation

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult Patient with Indications for Catheter Ablation of Atrial Fibrillation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 Year
Number of participants with adverse events that are related to underlying disease (cardiovascular events not related to atrial fibrillation cryoablation)
Time Frame: 1 Year
1 Year
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
Above parameters will be assessed only during the procedure of cryoablation
Number of participants with antiarrhythmic drug treatment at 12 months
Time Frame: 1 Year
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

March 21, 2022

Study Registration Dates

First Submitted

December 5, 2016

First Submitted That Met QC Criteria

January 31, 2017

First Posted (Estimate)

February 1, 2017

Study Record Updates

Last Update Posted (Actual)

April 1, 2022

Last Update Submitted That Met QC Criteria

March 21, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • PRAF-CA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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