NCT03040037

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2016

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2022

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

4.5 years

First QC Date

December 5, 2016

Last Update Submit

March 21, 2022

Conditions

Atrial Fibrillation

Outcome Measures

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

    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 Outcomes (4)

  • 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

  • Number of participants with antiarrhythmic drug treatment at 12 months

    1 Year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult Patient with Indications for Catheter Ablation of Atrial Fibrillation

You may qualify if:

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

You may not qualify if:

  • Left atrial thrombosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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, 197341, Russia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2016

First Posted

February 1, 2017

Study Start

January 1, 2017

Primary Completion

July 1, 2021

Study Completion

March 21, 2022

Last Updated

April 1, 2022

Record last verified: 2022-03

Locations

RU(1)