Validation Study of Frontier X Plus (FX+) Device

NCT06471764 | Not Yet Recruiting DMC

• 1 other identifier: FF_DD_0104
• Study Type: observational
• Target: 125
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective of this study is to validate the specificity and sensitivity of FX+ detecting atrial fibrillation (AF) in both AF and non-AF subjects using a comparative approach, which involves using both a US FDA-cleared gold standard 12-lead and a consumer device which stores ECG (FX2 consumer model used to store the ECG for analysis retrospectively). The results obtained from this clinical investigation will serve as evidence for larger clinical investigation designs for this non-invasive and fully mobile method of continuous AF measurement in the adult population, including those with known or unknown cases of AF. The ultimate goal of this study is to establish the effectiveness of this novel approach in detecting and monitoring AF, which could potentially revolutionize the field of remote cardiac monitoring and improve the quality of care for patients with AF and other cardiac arrhythmias.

Conditions

Atrial Fibrillation

Keywords

Validation; ECG; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Validation of reliability of Frontier X Plus (FX+) to produce a clinically equivalent waveform in agreement to a gold-standard 12-lead ECG's Lead-1 reference

  1\. Validation of reliability of Frontier X Plus (FX+) to produce a clinically equivalent waveform in agreement to a gold-standard 12-lead ECG's Lead-1 reference by comparing: a. Quantitative review of RR intervals for date and time-matched segments b. Cardiologist naked-eye review and comparison of date and time-matched segments 2. Evaluate the Sensitivity and Specificity of the AF detection by Frontier X Plus (FX+) • Comparative 30-second rhythm analysis for AF detection obtained simultaneously from FX+ along with the 12-lead ECG (30-second recordings, repeated twice, consecutively)

  6 months

Study Arms (1)

FX+ and 12-Lead ECG Monitor Recording

Device: FX+ and 12-Lead ECG Recording

Interventions

FX+ and 12-Lead ECG Recording DEVICE

While lying down, subjects will wear the FX+, a chest strap device which will measure cardiac electrical activity to generate a continuous heart rate measurement. Simultaneously, electrodes for the 12-Lead ECG will be placed on the chest and arms/legs to record the electrical activity. Two 30-second recordings from the FX+ will be taken simultaneously with the 12-lead ECG with no more than a 3-minute interval between the two recordings.

Also known as: Clinical Data Collection

FX+ and 12-Lead ECG Monitor Recording

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will be a single center study conducted at the University of Rochester Medical Center between the Pulmonary Hypertension team and the Department of Cardiology. Patients who currently receive care by the Pulmonary Hypertension providers (Daniel Lachant, DO, R. James White, MD PhD, Dominic Roto, DO, and Kristine Ferrin, NP) or by a provider in the Department of Cardiology either outpatient or inpatient, will be recruited for study participation. We plan to enroll 125 subjects total (85 non-atrial fibrillation and 40 with atrial fibrillation). No participant will be excluded based on age, race, gender, or ethnic background and we will be sure to explain the subject matter and answer questions for all participants to their satisfaction. Pediatric participants \<18 years old will not be included as the device is indicated for use in those 18+. Non-English speaking adults will not be enrolled as we have seen less than 10 patients who do not speak English in our clinic.

You may qualify if:

• Age \>18 years Fluent in the English language

You may not qualify if:

• Acute or critical cardiac abnormality that may impair data collection as determined by the investigator Mechanical ventilation or any other kind of life support system Acute, serious, or life-threatening illness due to any cause (renal failure, liver failure, etc.) Pregnant or lactating individual Inability to tolerate FX+ device or 12-lead ECG placement.

Sponsors & Collaborators

• Fourth Frontier Technologies Pvt Ltd.: lead
• University of Rochester: collaborator

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Daniel Dr Lachant, MD

CONTACT

585-486-0147; daniel_lachant@urmc.rochester.edu

Peter Dr Joseph, MB

CONTACT

585-486-0147; peter@fourthfrontier.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: July 1, 2024
• Primary Completion: January 20, 2025
• Study Completion: April 20, 2025
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share