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7-day Holter Monitoring in Adult Patients With Recent IS or TIA, to Measure the Prevalence of Paroxysmal Atrial Fibrillation Including Episodes Less Than 30 Seconds: Transversal Study

NCT04963647 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 660

Last updated 2021-07-15

No results posted yet for this study

Summary

The main outcome of this study will be to compare the prevalence of PA AF episodes longer than 30 seconds versus the prevalence of PA AF episodes including episodes shorter than 30 seconds, in adult patients who survived IS or TIA with no previous history of AF, after 7-day Holter monitoring. Based on the previous assumptions, the secondary objectives of the project will be:

1. To compare the prevalence of patients diagnosed with BAF after 24-hour, 72-hour, and 7-day Holter monitoring.
2. To study the feasibility of using information obtained from the ECG during sinus rhythm, for example the characteristics of the P-wave, to predict the presence of PA AF and BAF.
3. To Collect a new database of multi-monitored, high-resolution, long-term ECG signals. The data will be used by the My-Atria consortium for research purposes, for the development and validation of arrhythmia detection algorithms.

The results of the study are intended to have an impact on how AF is screened, diagnosed, and treated. The results will also contribute to the choice of the most appropriate secondary stroke prevention modality, which therefore refers to the treatment of subjects who have already had an episode of IS or TIA.

Conditions

Interventions

DIAGNOSTIC_TEST

Adult subjects diagnosed with IS or TIA

From the moment the person decides to participate, the patient will undergo the first 24-hour cycle of monitoring with a high-resolution 12-lead Holter. The following day, the Holter report generated will be analyzed by an expert electrocardiographic. After the removal of the first Holter, the study subject will undergo a second monitoring with a 3-lead Holter device for a duration of 6 days, followed by decontamination of the device and archiving of data The electronic data relating to the monitoring periods with Holter will be analyzed with various high-sensitivity AF detection algorithms in order to identify the outcome of the study.

Sponsors & Collaborators

  • Mortara Instrument Europe S.r.l.

    collaborator UNKNOWN

  • Azienda Usl di Bologna

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-16
Primary Completion
2022-07-16
Completion
2023-06-16

Countries

  • Italy

Study Locations

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Entities

Diseases

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 NCT04963647 on ClinicalTrials.gov