ECG Monitoring Short vs Middle Term After Atrial Fibrillation Ablation (CLARITY)

July 9, 2025 updated by: Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
To compare the number of patients with AF recurrence detected in a 24-h Holter monitoring with a 5-day record.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients who are evaluated 3 months after having AF ablation surgery.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AF recurrence
Time Frame: up to 5 days
Number of patients with AF recurrence detected in a cardio loop monitoring.
up to 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects
Time Frame: up to 5 days
skin injuries, losses, allergies, etc.
up to 5 days
Burden of AF
Time Frame: up to 5 days
Burden of AF in the two groups (Day/Hours/minuts)
up to 5 days
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
up to 5 days
Total time of noise
Time Frame: up to 5 days
Total time of noise in each group
up to 5 days
Total time analized
Time Frame: up to 5 days
Total time analized in each group
up to 5 days
premature losses
Time Frame: up to 5 days
loss of connection of the device before 5 days
up to 5 days
time to analyze
Time Frame: min:hours
time it takes to analyze and interpret the logs obtained, in minutes.
min:hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Actual)

July 1, 2024

Study Completion (Actual)

June 1, 2025

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

July 17, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Actual)

July 10, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Clarity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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