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Single-lead ECG Screening for Atrial Fibrillation

(AFRESHE Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
Disqualifiers: Atrial fibrillation, Cardiac devices, Allergy, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this prospective, non-randomized pilot study is to learn whether predictions from a previously validated 12-lead ECG-based artificial intelligence (AI) algorithm (ECG-AI) identify people more likely to have undiagnosed atrial fibrillation (AF).

The main questions it aims to answer are:

Do people predicted to have high risk of AF using ECG-AI have a higher rate of new AF diagnosis using 1L ECG screening compared with people predicted to have a low risk? Do AI-based AF risk estimates from the 12-lead ECG correlate with AF risk estimates from the 1L ECG? Do people find 1L ECG screening for AF acceptable and useful?

Participants will:

Undergo screening with 1L ECG mailed to their home Complete a survey assessing attitudes toward 1L ECG screening Complete a 14-day patch monitor on 1 or 2 occasions depending on 1L ECG results

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 50 and 90 and get care at an MGH primary care or cardiology clinic.
* Willing to provide consent to participate in the study to access data from electronic health records (EHR)
* At least 1 12-lead ECG obtained within 5 years prior to study start date for AF risk estimation
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
No physical visits required

Initial Assessment

Participants undergo screening with 1L ECG mailed to their home and complete a survey assessing attitudes toward 1L ECG screening

2 weeks
Remote participation

Patch Monitoring

Participants complete a 14-day patch monitor on 1 or 2 occasions depending on 1L ECG results

2-4 weeks
Remote participation

Follow-up

Participants are monitored for incident AF at 12 months using linked EHR and/or the results of the study patch monitors

12 months

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Low-riskActive Control2 Interventions
Group II: High-riskActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

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