NCT07278089

Brief Summary

To evaluate the feasibility of specific echocardiographic parameters as criteria for AF screening and to determine the AF detection yield of scheduled extended ECG monitoring compared to contemporary care.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
81mo left

Started Mar 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

Study Progress15%
Mar 2025Dec 2032

Study Start

First participant enrolled

March 17, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2031

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Last Updated

December 11, 2025

Status Verified

November 1, 2025

Enrollment Period

6.8 years

First QC Date

November 29, 2025

Last Update Submit

November 29, 2025

Conditions

Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (1)

  • the detection of AF either by 12-lead ECG or any episodes of AF lasting ≥ 30 seconds by the single-lead ECG or 7-day continuous recording.

    2 years

Study Arms (2)

study arm

ACTIVE COMPARATOR
Diagnostic Test: study arm

control arm

NO INTERVENTION

Interventions

study armDIAGNOSTIC_TEST

Scheduled cardiac rhythm monitoring every 3 months using extended continuous ECG monitoring

study arm

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • LAE: defined as LAD ≥ 45 mm or LAVI \> 34 ml/m2;
  • LVH: defined as LV septal or posterior wall thickness ≥ 15 mm;
  • E/e' \> 14;
  • grade II or III diastolic dysfunction;
  • VHD;
  • HF: defined as LVEF \< 40% or LVEF ≥40% with clinical presentation compatible with Framingham criteria, New York Heart Association functional classification II-IV, and N-terminal pro-B type natriuretic peptide (NT-proBNP) \> 125 pg/ml.

You may not qualify if:

  • Patients with a history of AF or atrial flutter, congenital heart disease, acute coronary syndrome undergoing urgent percutaneous coronary intervention within 3 months, uncontrolled hyperthyroidism, end-stage renal disease, unstable hemodynamic status or any known major comorbidities or medical conditions with expected life expectancy less than 1 year are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Tze-Fan Chao, PhD

CONTACT

886-2-28727794eyckeyck@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 29, 2025

First Posted

December 11, 2025

Study Start

March 17, 2025

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2032

Last Updated

December 11, 2025

Record last verified: 2025-11

Locations

TW(1)