NCT05959915

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

July 17, 2023

Last Update Submit

July 9, 2025

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • AF recurrence

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

    up to 5 days

Secondary Outcomes (7)

  • Adverse effects

    up to 5 days

  • Burden of AF

    up to 5 days

  • Number of patients with recurrent AF / atrial flutter / atrial tachycardia

    up to 5 days

  • Total time of noise

    up to 5 days

  • Total time analized

    up to 5 days

  • +2 more secondary outcomes

Interventions

device e-patch ImplantationDEVICE

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.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic Barcelona

Barcelona, 08036, Spain

Location

Related Publications (9)

  • Andrade JG, Macle L, Nattel S, Verma A, Cairns J. Contemporary Atrial Fibrillation Management: A Comparison of the Current AHA/ACC/HRS, CCS, and ESC Guidelines. Can J Cardiol. 2017 Aug;33(8):965-976. doi: 10.1016/j.cjca.2017.06.002. Epub 2017 Jun 9.

    PMID: 28754397BACKGROUND

  • Forleo GB, Casella M, Dello Russo A, Moltrasio M, Fassini G, Tesauro M, Tondo C. Monitoring Atrial Fibrillation After Catheter Ablation. J Atr Fibrillation. 2014 Apr 30;6(6):1040. doi: 10.4022/jafib.1040. eCollection 2014 Apr-May.

    PMID: 27957062BACKGROUND

  • Forkmann M, Schwab C, Edler D, Vevecka A, Butz S, Haller B, Brachmann J, Busch S. Characteristics of early recurrences detected by continuous cardiac monitoring influencing the long-term outcome after atrial fibrillation ablation. J Cardiovasc Electrophysiol. 2019 Oct;30(10):1886-1893. doi: 10.1111/jce.14109. Epub 2019 Aug 26.

    PMID: 31397518BACKGROUND

  • Aljuaid M, Marashly Q, AlDanaf J, Tawhari I, Barakat M, Barakat R, Zobell B, Cho W, Chelu MG, Marrouche NF. Smartphone ECG Monitoring System Helps Lower Emergency Room and Clinic Visits in Post-Atrial Fibrillation Ablation Patients. Clin Med Insights Cardiol. 2020 Jan 20;14:1179546820901508. doi: 10.1177/1179546820901508. eCollection 2020.

    PMID: 32009826BACKGROUND

  • Kimura T, Aizawa Y, Kurata N, Nakajima K, Kashimura S, Kunitomi A, Nishiyama T, Katsumata Y, Nishiyama N, Fukumoto K, Tanimoto Y, Fukuda K, Takatsuki S. Assessment of atrial fibrillation ablation outcomes with clinic ECG, monthly 24-h Holter ECG, and twice-daily telemonitoring ECG. Heart Vessels. 2017 Mar;32(3):317-325. doi: 10.1007/s00380-016-0866-2. Epub 2016 Jul 6.

    PMID: 27385021BACKGROUND

  • Sikorska A, Baran J, Piotrowski R, Krynski T, Szymot J, Soszynska M, Kulakowski P. Daily ECG transmission versus serial 6-day Holter ECG for the assessment of efficacy of ablation for atrial fibrillation - the AGNES-ECG study. J Interv Card Electrophysiol. 2022 Nov;65(2):373-380. doi: 10.1007/s10840-022-01166-4. Epub 2022 Mar 3.

    PMID: 35244820BACKGROUND

  • Hermans ANL, Gawalko M, Pluymaekers NAHA, Dinh T, Weijs B, van Mourik MJW, Vorstermans B, den Uijl DW, Opsteyn L, Snippe H, Vernooy K, Crijns HJGM, Linz D, Luermans JGLM. Long-term intermittent versus short continuous heart rhythm monitoring for the detection of atrial fibrillation recurrences after catheter ablation. Int J Cardiol. 2021 Apr 15;329:105-112. doi: 10.1016/j.ijcard.2020.12.077. Epub 2021 Jan 4.

    PMID: 33412184BACKGROUND

  • Hillmann HAK, Soltani S, Mueller-Leisse J, Hohmann S, Duncker D. Cardiac Rhythm Monitoring Using Wearables for Clinical Guidance before and after Catheter Ablation. J Clin Med. 2022 Apr 26;11(9):2428. doi: 10.3390/jcm11092428.

    PMID: 35566556BACKGROUND

  • Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.

    PMID: 32860505RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of AF Unit

Study Record Dates

First Submitted

July 17, 2023

First Posted

July 25, 2023

Study Start

July 1, 2023

Primary Completion

July 1, 2024

Study Completion

June 1, 2025

Last Updated

July 10, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)