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Screen group for Atrial Fibrillation

N/A

Recruiting

Led By Stavros Stavrakis, MD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 seconds

Awards & highlights

Study Summary

"This trial is being conducted at one location and is not randomized. The goal is to collect data that will be submitted to the FDA to support the clearance of a smartwatch ECG device."

Who is the study for?

This trial is for men and women over 18 who can understand and sign a consent form. Participants must be patients at the OU Cardiac Electrophysiology Outpatient Clinic.Check my eligibility

What is being tested?

The study aims to validate the ECG function of a smartwatch, collecting data needed for FDA approval. It's a single-center study that isn't randomized, focusing on getting this device cleared by the FDA.See study design

What are the potential side effects?

Since this trial involves non-invasive monitoring with a smartwatch ECG, there are minimal expected side effects, primarily related to potential skin irritation from wearing the device.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 seconds

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 seconds

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 seconds for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

QRS amplitude

Trial Design

1Treatment groups

Experimental Treatment

Group I: Screen groupExperimental Treatment1 Intervention

This is a single-center, non-randomized open study with a single-patient clinical trial design (i.e., the patients serve as their own control).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor

455 Previous Clinical Trials

95,853 Total Patients Enrolled

13 Trials studying Atrial Fibrillation

2,608 Patients Enrolled for Atrial Fibrillation

Stavros Stavrakis, MDPrincipal InvestigatorUniversity of Oklahoma

5 Previous Clinical Trials

308 Total Patients Enrolled

3 Trials studying Atrial Fibrillation

223 Patients Enrolled for Atrial Fibrillation

Stavros Stavros, MDPrincipal InvestigatorUniversity of Oklahoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently being actively enrolled in this ongoing medical study?

"Indeed, information on clinicaltrials.gov shows that this investigation is currently seeking suitable participants. The trial was initially listed on April 1st, 2024 and was most recently revised on February 26th of the same year. A total of 70 individuals are being sought at a single designated site for enrollment in the study."

Answered by AI

What is the upper limit for participant enrollment in this research investigation?

"Indeed, as per clinicaltrials.gov data, this particular research endeavor is presently in the process of seeking suitable candidates. The trial was initially listed on April 1st, 2024, and most recently updated on February 26th, 2024. Recruitment aims to enlist a total of 70 participants at one designated site."

Answered by AI

What are the eligibility criteria for individuals seeking to participate in this clinical study?

"Inclusion Criteria: The trial seeks 70 participants aged between 18 and 90 diagnosed with atrial fibrillation. Additionally, candidates must satisfy the subsequent conditions: - Individuals of both genders above 18 years old are eligible. - Capable of comprehending and providing written informed consent before any study procedures commence. - Currently under care at the OU Cardiac Electrophysiology Outpatient Clinic."

Answered by AI

Is there an age restriction for participation in this research, specifically excluding those under the age of 30?

"The inclusion criteria specify that study participants must be aged between 18 and 90 years. Notably, there are separate trials available for individuals under 18 as well as those over the age of 65, with a total of 8 and 485 trials respectively catered to these specific age groups."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SmartWatch ECG Evaluation Trial I

Stavros Stavrakis 2024. "SmartWatch ECG Evaluation Trial I". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05942274.

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