Optimal Detection of Atrial Fibrillation in TIA

Summary

Transient ischemic attack (TIA) is a common neurologic emergency. Although the detection of atrial fibrillation (AF) has identical consequences for preventive therapy in patients with ischemic stroke and TIA, the management setting and diagnostic pathways frequently differ substantially between both manifestations. Despite these differences between stroke and TIA patients, previous studies have investigated diagnostic work-up for AF primarily in stroke patients. Thus, there is no common practice or "gold standard" of rhythm monitoring for TIA patients in most healthcare systems and the optimal method and duration of cardiac monitoring for TIA patients is currently unknown. This is likely to result in a substantial under-diagnosis of AF in TIA patients, failure to initiate appropriate secondary preventive medication (i.e. anticoagulation) and ultimately the occurrence of many otherwise preventable strokes.

The primary research question of the trial is whether prolonged ECG recording using a subcutaneously implanted event recorder increases the detection rate of paroxysmal AF (pAF) within 6 months after the event in patients with recent TIA both compared to 24-h ECG recording and compared to prolonged ECG recording using non-invasive continuous ECG recording for 28 days AND To determine whether 28-day non-invasive ECG monitoring increases the detection rate of pAF within 6 months after the event compared to 24-h ECG recording.

Conditions

• Atrial Fibrillation
• Transient Ischemic Attack

Interventions

DEVICE

Subcutaneously implanted event recorder (REVEAL LINQ)

Patients receive a subcutaneously implantable cardiac device (REVEAL LINQ).

DEVICE

28-day non-invasive continuous ECG monitoring (patch)

Patients receive a non-invasive continuous ECG monitoring (patch)

Sponsors & Collaborators

• Medtronic Bakken Research

  collaborator INDUSTRY

• Coordinating Centre for Clinical Trials Heidelberg

  collaborator UNKNOWN

• Wuerzburg University Hospital

  collaborator OTHER

• Alfried Krupp Krankenhaus

  lead OTHER

Principal Investigators

• Roland Veltkamp, MD · Initiator of study, leader PI

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-12

Primary Completion

2024-03-15

Completion

2025-08-31

Countries

• Germany
• Spain

Study Locations