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Determine AF Burden With PPG Trial - Detection and Quantification of Episodes of Atrial Fibrillation

NCT04563572 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2022-11-15

No results posted yet for this study

Summary

In this prospective single-center trial, a wearable photoplethysmographic (PPG) sensor coupled with a cloud analytics service will be used to detect and quantify atrial fibrillation (AF) episodes in patients with known paroxysmal AF. Patients will simultaneously receive the PPG sensor in form of a smartwatch or bracelet and a Holter ECG for 48 hours. Correctly identified AF episodes and AF burden determined by both methods will be compared.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DEVICE

PPG Smartwatch

Participants will then receive a PPG sensor in form of a smartwatch) model and will be instructed to wear them continuously for 48 hours. Simultaneously, a 48-hour Holter ECG will be performed. Start time on the PPG-sensor and the Holter ECG will be matched and continuous heart rhythm and -rate monitoring will be initiated. Patients will wear the devices over a 48-hour period of time.

Sponsors & Collaborators

  • Preventicus GmbH

    collaborator INDUSTRY

  • Manufacture Modules Technologies SA

    collaborator UNKNOWN

  • GETEMED GmbH

    collaborator UNKNOWN

  • Eurostars

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Jens Eckstein, MD, PhD · University Hospital, Basel, Switzerland

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-13
Primary Completion
2022-07-28
Completion
2022-07-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04563572 on ClinicalTrials.gov