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RECRUITING
NCT06542770
NA

Atrial Anomalies Predict Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Cryptogenic Stroke

Sponsor: Parc de Salut Mar

View on ClinicalTrials.gov

Summary

Cryptogenic stroke (CS) causes about 30% of admissions to a stroke unit. Silent paroxysmal atrial fibrillation (PAF) is believed to be the underlying cause of a significant proportion of patients. The use of implantable cardiac monitors (ICM) early after the CS has demonstrated benefits in the diagnostic yield, but the indication for ICM in the current guidelines remains unclear. Atrial contraction strain (ACS) evaluated by cardiac ultrasound could be of help to select the patients more prone to suffer from silent PAF. The purpose of this investigation is to conduct a randomized prospective unicentric study to evaluate the usefulness of ICM for early detection of silent PAF episodes in patients with CS. Clinical and ultrasound predictors of PAF occurrence (ACS) will be studied in order to define patients needing a closer follow-up.

Official title: Subtle Ultrasound Atrial Anomalies Predicts the Early Diagnosis of Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Patients With Cryptogenic Stroke. A Randomized Trial

Key Details

Gender

All

Age Range

50 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2021-01-01

Completion Date

2024-12

Last Updated

2024-08-07

Healthy Volunteers

No

Interventions

DEVICE

Early implant of cardiac monitor

ICM implant 3-4 days after the stroke and prior to discharge. All devices (Abbott Confirm or Jot) were implanted subcutaneously under local anaesthesia in the left chest region and programmed with an specific algorithm for AF detection set at 30 seconds for detection. All patients were included in remote monitoring system (Merlin), which was programmed to send alerts in case of registering episodes qualifying for AF detection, and a monthly routine registration. All ICM recordings were reviewed by a specialized cardiologist.

Locations (1)

Hospital del Mar

Barcelona, Spain