NCT04508491

Brief Summary

Compare the difference of cognitive function between different treatment strategy in patients with persistent atrial fibrillation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable

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

August 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2024

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2025

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

3.3 years

First QC Date

August 9, 2020

Last Update Submit

January 14, 2026

Conditions

Atrial Fibrillation, PersistentCognitive Function

Keywords

Atrial FibrillationCognitive Function

Outcome Measures

Primary Outcomes (2)

  • Cognitive function

    MOCA questionnaire

    12 months

  • Cognitive function

    brain MRI

    12 months

Secondary Outcomes (3)

  • Quality of Life questionnaire

    12 months

  • Hospitalization for cardiovascular cause

    12 months

  • all cause mortality

    12 months

Study Arms (2)

Rhythm control

EXPERIMENTAL

Rhythm control with medication or any procedure

Other: Rhythm control

Rate control

ACTIVE COMPARATOR

Rate control with medication or any procedure

Other: Rate control

Interventions

Rhythm controlOTHER

Rhythm control with medications or any procedure

Rhythm control
Rate controlOTHER

Rate control

Rate control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those who meet the diagnosis of persistent atrial fibrillation, meet one of the following conditions:
  • The twelve-lead electrocardiogram is used to diagnose atrial fibrillation, and to cooperate with clinical diagnosis.
  • hours ECG diagnosis 100% atrial fibrillation, with clinical diagnosis.
  • The seven-day ECG recorder diagnosed 100% atrial fibrillation.
  • Willing to accept treatment recommended by doctors, containing anticoagulant, and cooperate with examination and treatment in the coming year.

You may not qualify if:

  • Unwilling to sign the clinical trial consent form.
  • Unable to complete the cognitive function questionnaire.
  • Unable to complete brain MRI examination due to various reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Heart Rate

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2020

First Posted

August 11, 2020

Study Start

November 30, 2020

Primary Completion

March 8, 2024

Study Completion

February 26, 2025

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)