Skip to main content
OpenTrials
Completed

NCT Number: NCT04508491

Cognitive Function in Patients With Persisted Atrial Fibrillation

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

The prevalence of atrial fibrillation (AF) had been increasing for the past decade. The increase of AF was attributed to the aging of the population and the increased awareness of the disease among people and the primary physicians. However, we have not achieved the consensus whether aggressive rhythm control or conservative rate control is better in a patient with asymptomatic persisted AF. We do prescribe anti-coagulant for stroke prevention, but which treatment strategy is best for the patients is uncertain.

The clinical trial of catheter-based ablation for rhythm control compared to traditional medication control has not shown the benefit of reducing all-cause mortality, but it did show a reduction of re-hospitalization and the recurrence of AF. On the contrary, the study in heart failure patients had shown a significant benefit applying catheter-based rhythm control strategy to reduce all-cause mortality. The different results of these two trials told us the benefit of rhythm control is not easily to be seen in a short-term, but could be seen in a long term or in high risk patients. The association between AF and cognitive impairment has also been reported in observation cohort. However, there is no sold evidence in clinical trials to show the improvement of cognitive function by treating atrial fibrillation. One study did show improvement of cognitive function with questionnaire, but the other showed new lesion detected by traditional magnetic resonance imaging (MRI) after ablation, though the lesion resolved after one year of follow-up. There is no clear answer to which treatment strategy is better for the patients' cognitive function。 Therefore, we designe a prospective, randomized, blind endpointtrial. We will enroll the patients with persisted AF, and use advanced MRI (DTI/SWI) and questionnaire to longitudinally study the cognitive function change of the patients before and after the initiation of anti-coagulant agents, before and after the catheter-based ablation, and use this as a surrogate to understand the best treatment strategy for these AF patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.
  • 24 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.

Exclusion criteria

  • 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

Treatment and study plan

Rhythm control

Other

Rhythm control with medications or any procedure

Rate Control

Other

Rate control

Primary outcomes

  1. Cognitive function

    Time frame: 12 months

    MOCA questionnaire

  2. Cognitive function

    Time frame: 12 months

    brain MRI

Secondary outcomes

  1. Quality of Life questionnaire

    Time frame: 12 months

    SF-36 questionnaire

  2. Hospitalization for cardiovascular cause

    Time frame: 12 months

  3. all cause mortality

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

The Best Treatment Strategy for the Reservation of Cognitive Function in Patients With Persisted Atrial Fibrillation

Acronym: SMART-AF

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Aug 11, 2020
Registry last updated
Jan 16, 2026

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.

Published trials that share one or more normalized conditions with this study.