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Detection of Silent Atrial Fibrillation aFter Ischemic StrOke

NCT02684825 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2023-06-29

No results posted yet for this study

Summary

The primary objective of this study is to evaluate whether, in patients with first-ever atherothrombotic or lacunar stroke without any previous history of atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT), the detection of AF/AFL/AT (silent or symptomatic) by using a continuous cardiac rhythm monitoring with implantable loop recorder (ILR) during the first 12 months of observation is higher than the detection by using a standard cardiac monitoring (physical exam, 12-lead electrocardiogram \[ECG\] at baseline, 3, 6, and 12 months and Holter ECG at 3 months) in the same period of time.

Conditions

Interventions

DEVICE

Reveal LINQTM- LNQ11 Internal Loop Recorder plus standard cardiac monitoring

Reveal LINQTM- LNQ11 continuously monitors cardiac electric activity for up to three years.

Sponsors & Collaborators

  • Associazione Italiana Aritmologia e Cardiostimolazione (A.I.A.C.) - Stefano Strano, MD

    collaborator UNKNOWN

  • Boehringer Ingelheim

    collaborator INDUSTRY

  • Medtronic Italia S.p.A.

    collaborator UNKNOWN

  • Bayer S.p.A

    collaborator UNKNOWN

  • Danilo Toni

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • Italy

Study Locations

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Entities

Diseases
Companies

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 NCT02684825 on ClinicalTrials.gov