Triggers and Risk Factors for Recurrence of Atrial Arrhythmias With the Use of Long-term Monitoring

NCT ID: NCT05526170

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 182 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2024-09-30

Brief Summary

A prospective cohort study to evaluate the association between various triggers encountered in daily life and induction of atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia and premature atrial contractions) with the use of long-term monitoring devices. The collected data of personalized triggers and risk factors will be used to define the individual phenotype of atrial arrhythmia.

Conditions

Atrial Fibrillation; Atrial Flutter; Atrial Arrhythmia; Atrial Tachycardia; Premature Atrial Contractions; Arterial Hypertension; Sleep Disorder; Sleep Apnea; Stress; Physical Inactivity; Overexertion; Alcohol Drinking; Caffeine Dependence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with previously diagnosed paroxysmal or persistent atrial fibrillation

Patients with previously diagnosed paroxysmal or persistent atrial fibrillation who are in sinus rhythm at inclusion time. During trial period subjects will be monitored for different atrial arrhythmias and divided into the following subgroups: atrial fibrillation, atrial flutter, atrial tachycardia, premature atrial contractions (bigeminy, trigeminy, couplets), multiple atrial arrhythmias and no arrhythmia detected.

Devices for long-term monitoring of objective and subjective parameters of the body

Intervention Type: DEVICE

Patients will use a 1-lead Holter ECG (Bittium Faros) for heart rhythm and physical activity analysis, a wearable wrist-worn device with photoplethysmography and 6-lead ECG for heart rhythm analysis, a sleep tracking mat (Withings sleep analyser) for sleep analysis, a smartphone with triggers application for entering the subjective triggers (stress, coffee, alcohol intake and others), a 48-hour ambulatory blood pressure monitor for 2 days and a regular blood pressure monitor for up to 5 days. Patients will be monitored for up to 7 days with the described system of devices. In addition, patients will receive investigations of heart echocardiography, laboratory tests and surveys to evaluate the system and the use of acquired information.

Interventions

Devices for long-term monitoring of objective and subjective parameters of the body

Patients will use a 1-lead Holter ECG (Bittium Faros) for heart rhythm and physical activity analysis, a wearable wrist-worn device with photoplethysmography and 6-lead ECG for heart rhythm analysis, a sleep tracking mat (Withings sleep analyser) for sleep analysis, a smartphone with triggers application for entering the subjective triggers (stress, coffee, alcohol intake and others), a 48-hour ambulatory blood pressure monitor for 2 days and a regular blood pressure monitor for up to 5 days. Patients will be monitored for up to 7 days with the described system of devices. In addition, patients will receive investigations of heart echocardiography, laboratory tests and surveys to evaluate the system and the use of acquired information.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with previously diagnosed paroxysmal or persistent atrial fibrillation who are in sinus rhythm at inclusion time.
• An informed consent is signed by the patient.

Exclusion Criteria

• The qualifying episode of AF has never been documented in ECG or Holter ECG monitoring.
• Patients with atrial fibrillation, atrial flutter or atrial tachycardia at inclusion time.
• Patients with permanent atrial fibrillation or permanent atrial flutter.
• Age <18 years.
• Patients with a pacemaker or an implanted cardiovert-defibrillator.
• Patients suffering from dementia or other severe neurological disorders and thus incapable to participate.
• Patients who present with antisocial behavior and/or do not want to participate in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaunas University of Technology

OTHER

Sponsor Role: collaborator

Vilnius University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Vilnius University Santaros Clinics

Vilnius, Vilniaus, Lithuania

Countries

Lithuania

Other Identifiers

TriggersAF

Identifier Type: -

Identifier Source: org_study_id