NCT05565781

Smartwatch and External Holter Monitoring to Detect Atrial Fibrillation in Patients With Cryptogenic Stroke

Impact of Non-invasive Remote Monitoring Via Wearable Technologies for Detection of Atrial Fibrillation in Patients With Cryptogenic Stroke

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

Stroke recurrence largely depends on the detection of the cause and the control of vascular risk factors, with occult atrial fibrillation (AF) being one of the most important. Prolonged ambulatory cardiac monitoring is recommended for detecting occult AF. Currently, there are non-invasive monitoring devices such as the textile Holter that have proven to be useful for monitoring for up to 30 days but not longer. Another alternative is smartwatches, although they must be validated for use in the elderly population who have had a stroke.

Detailed description

The primary objective is to demonstrate that the protocol of ambulatory cardiac monitoring with wearable devices for 12 months allows detection of a higher percentage of occult AF than monitoring for 30 days. The secondary objectives will be to demonstrate the internal validity of smartwatches against insertable cardiac recorders for the detection of AF. To evaluate the usability and adherence to the use of smartwatches in patients with stroke. Detect predictors that can help detect long-term occult AF. Determine the profile of vascular events in each group. Detect predictors of vascular recurrence defined as stroke recurrence, incidence of cerebral hemorrhage, heart failure, myocardial infarction or vascular death.

Conditions

• Paroxysmal Atrial Fibrillation
• Cryptogenic Stroke

Interventions

Type	Name	Description
DEVICE	ECG smartwatch	Testing ECG smartwatch to detect AF or potential signs of AF
DEVICE	Insertable Cardiac Monitor (ICM)	Gold-standard cardiac monitor for comparison of testing device (ECG smartwatch)
DEVICE	External ECG Monitoring	Regular cardiac monitor for diagnosis of AF

Timeline

• Start date: 2022-03-28
• Primary completion: 2025-06-01
• Completion: 2026-09-01
• First posted: 2022-10-04
• Last updated: 2025-04-04

Locations

1 site across 1 country: Spain