NCT07437456

Brief Summary

Multicenter Non-Interventional Real-World Clinical Practice Registry of Patients with Atrial Fibrillation. The primary objective of the registry is an epidemiological assessment of the characteristics, clinical outcomes, and therapeutic approaches in patients with atrial fibrillation and a CHA₂DS₂-VASc score of no more than 2 for men and no more than 3 for women.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
28mo left

Started Sep 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

February 22, 2026

Last Update Submit

February 22, 2026

Conditions

Keywords

Atrial FibrillationAnticoagulant TherapyThromboembolic Complications

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence of thromboembolic complications

    To assess the cumulative incidence of atrial fibrillation-related thromboembolic complications (including transient ischaemic attack, ischaemic stroke, and systemic thromboembolism) in patients with initially low risk over the follow-up period.

    6, 12, 18, 24, 30, 36 month

Secondary Outcomes (13)

  • Number of Atrial Fibrillation Paroxysms During the Follow-up Period

    6, 12, 18, 24, 30, 36 month

  • Rate of Hospitalizations Due to Atrial Fibrillation Paroxysm During the Follow-up Period

    6, 12, 18, 24, 30, 36 months

  • Rate of Catheter Ablation of Pulmonary Vein Ostia During the Follow-up Period

    6, 12, 18, 24, 30, 36 months

  • Complications of Anticoagulant Therapy

    6, 12, 18, 24, 30, 36 months

  • Proportion of Patients Who Switched from Antiplatelet Therapy (Acetylsalicylic Acid, Clopidogrel, Ticagrelor) to Oral Anticoagulants During the Follow-up Period

    6, 12, 18, 24, 30, 36 months

  • +8 more secondary outcomes

Study Arms (2)

Retrospective branch

The retrospective cohort will include patients who attended a physician consultation for atrial fibrillation three years ago and who met the study inclusion criteria at the time of that visit.

Prospective branch

All patients aged 18 to 64 years at the time of data registration, with a specialist-confirmed diagnosis of atrial fibrillation and a CHA₂DS₂-VASc score ranging from 0 to 2 for men and from 1 to 3 for women at the time of screening.

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Anonymized male and female patients aged 18 to 64 years suffering from atrial fibrillation confirmed by a specialist, with a CHA₂DS₂-VASc score ranging from 0 to 2 for men and from 1 to 3 for women.

You may qualify if:

  • Male or female patients aged 18 to 64 years at the time of data registration;
  • Presence of a specialist-confirmed diagnosis of atrial fibrillation;
  • CHA₂DS₂-VASc score ranging from 0 to 2 for men and from 1 to 3 for women.
  • Age under 18 years;
  • Age over 64 years;
  • CHA₂DS₂-VASc score greater than 2 for men and greater than 3 for women;
  • Inability to undergo screening examination and follow-up;
  • Organ or tissue transplantation less than 5 years prior to study enrollment;
  • Open heart surgery (coronary artery bypass grafting, valve replacement, reconstructive aortic surgery) within 6 months prior to study enrollment;
  • Established diagnosis of dementia of any severity and/or established diagnosis of moderate or severe encephalopathy, as well as other conditions precluding independent regular medication intake.
  • Prospective Part
  • Male or female patients aged 18 to 64 years at the time of data registration;
  • Presence of a specialist-confirmed diagnosis of atrial fibrillation;
  • CHA₂DS₂-VASc score ranging from 0 to 2 for men and from 1 to 3 for women at the time of screening.
  • Age under 18 years;
  • +6 more criteria

You may not qualify if:

  • Patient withdrawal of consent for further participation in the study;
  • Identification of factors precluding further patient participation in the study (at the physician's discretion).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eurasian Association of Therapists

Moscow, Russia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alexander Arutyunov, professor

    Eurasian Association of Therapists

    STUDY CHAIR

Central Study Contacts

Dmitrii Evdokimov, PhD

CONTACT

Alexander Vaskin

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2026

First Posted

February 27, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations