AF Screening in Patients With Abnormal Echocardiographic Parameters

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-17

Study Completion Date

2032-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrial Fibrillation (AF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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study arm

Group Type ACTIVE_COMPARATOR

study arm

Intervention Type DIAGNOSTIC_TEST

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

control arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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study arm

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. LAE: defined as LAD ≥ 45 mm or LAVI \> 34 ml/m2;
2. LVH: defined as LV septal or posterior wall thickness ≥ 15 mm;
3. E/e' \> 14;
4. grade II or III diastolic dysfunction;
5. VHD;
6. 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No