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Clinical Investigation to Determine the Accuracy and Benefit of Cardioskin™ in Patients With Known Atrial Fibrillation

NCT03964025 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-05-07

No results posted yet for this study

Summary

This is a prospective, non-randomized, comparative, single-arm, open label, multi- centre, post-market clinical investigation involving an expected 74 subjects (minimum 40, maximum 118) suffering from paroxysmal AF with the aim to determine the accuracy of "definitive" AF detection (≥30 seconds) of the Cardioskin™ as compared to a 3-lead Holter recorder in patients with known paroxysmal AF.

Conditions

Interventions

DEVICE

Wearing Cardioskin™ for 14 days

The current standard of care for diagnosing AF is through the use of a 24 hour Holter device. In this study, in addition to wearing the 3-lead Holter recorder for 24 hours, the subject will be wearing the Cardioskin™ for a period of 24 hours as well, after which the subject will continue wearing the Cardioskin™ alone for an additional period of 13 days.

Sponsors & Collaborators

  • Institut de Recherches Internationales Servier

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-01-01
Completion
2022-01-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT03964025 on ClinicalTrials.gov