ECG Monitoring Short vs Middle Term After Atrial Fibrillation Ablation

NCT ID: NCT05959915

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-06-01

Brief Summary

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

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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device 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Josep Lluis Mont Girbau

Head of AF Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Clínic Barcelona

Barcelona, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 28754397 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27957062 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31397518 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32009826 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27385021 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35244820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33412184 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35566556 (View on PubMed)

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.

Reference Type RESULT
PMID: 32860505 (View on PubMed)

Other Identifiers

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CLARITY

Identifier Type: -

Identifier Source: org_study_id

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