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ECG Monitoring Short vs Middle Term After Atrial Fibrillation Ablation

ECG Monitoring Short vs Middle Term After Atrial Fibrillation Ablation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05959915
Acronym
CLARITY
Enrollment
96
Registered
2023-07-25
Start date
2023-07-01
Completion date
2025-06-01
Last updated
2025-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief summary

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

Interventions

DEVICEdevice e-patch Implantation

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.

Sponsors

Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
AF recurrenceup to 5 daysNumber of patients with AF recurrence detected in a cardio loop monitoring.

Secondary

MeasureTime frameDescription
Burden of AFup to 5 daysBurden of AF in the two groups (Day/Hours/minuts)
Number of patients with recurrent AF / atrial flutter / atrial tachycardiaup to 5 daysNumber of patients with recurrent AF / atrial flutter / atrial tachycardia in two groups
Total time of noiseup to 5 daysTotal time of noise in each group
Adverse effectsup to 5 daysskin injuries, losses, allergies, etc.
premature lossesup to 5 daysloss of connection of the device before 5 days
time to analyzemin:hourstime it takes to analyze and interpret the logs obtained, in minutes.
Total time analizedup to 5 daysTotal time analized in each group

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026