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OpenTrials
Completed

NCT Number: NCT05959915

ECG Monitoring Short vs Middle Term After Atrial Fibrillation Ablation

To compare the number of patients with AF recurrence detected in a 24-h Holter monitoring with a 5-day record.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínic Barcelona

Barcelona, 08036, Spain

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have undergone an AF ablation procedure at the Hospital Clínic and have a 12-month follow-up planned.
  • Having been previously assessed by the AF nurse.
  • Having signed the informed consent.

Exclusion criteria

  • Extreme skin fragility at chest level
  • Allergy to latex or adhesive tape
  • No electrophysiology follow-up at the Clínic hospital.
  • Patients who are already included in other studies that may interfere with the expected results of this one.
  • Patients with cognitive impairment or disorientation.

Treatment and study plan

device e-patch Implantation

Device

The ePatch device (Phillips) was used. This device is attached to the sternum, using a specific dressing adapted for the device itself. Manufacturer's recommendations for skin preparation and placement will be followed.

The device will remain in place for 4-5 days, at which time the patient will be readmitted for data extraction and reading.

The team of research nurses will analyze the data through the ePatch platform and later, the electrophysiologists will review the results and make a diagnosis.

Primary outcomes

  1. AF recurrence

    Time frame: up to 5 days

    Number of patients with AF recurrence detected in a cardio loop monitoring.

Secondary outcomes

  1. Adverse effects

    Time frame: up to 5 days

    skin injuries, losses, allergies, etc.

  2. Burden of AF

    Time frame: up to 5 days

    Burden of AF in the two groups (Day/Hours/minuts)

  3. Number of patients with recurrent AF / atrial flutter / atrial tachycardia

    Time frame: up to 5 days

    Number of patients with recurrent AF / atrial flutter / atrial tachycardia in two groups

  4. Total time of noise

    Time frame: up to 5 days

    Total time of noise in each group

  5. Total time analized

    Time frame: up to 5 days

    Total time analized in each group

  6. premature losses

    Time frame: up to 5 days

    loss of connection of the device before 5 days

  7. time to analyze

    Time frame: min:hours

    time it takes to analyze and interpret the logs obtained, in minutes.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Acronym: CLARITY

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 25, 2023
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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