ECG Monitoring Short vs Middle Term After Atrial Fibrillation Ablation

Atrial Fibrillation Clinical Trial

— CLARITY  

Official title:

ECG Monitoring Short vs Middle Term After Atrial Fibrillation Ablation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05959915
• Other study ID #: CLARITY
• Status: Active, not recruiting
• Start date: July 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: September 2023
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 96
• Est. completion date: October 1, 2024
• Est. primary completion date: July 1, 2024
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Clínic Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 I — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AF recurrence	Number of patients with AF recurrence detected in a cardio loop monitoring.	up to 5 days
Secondary	Adverse effects	skin injuries, losses, allergies, etc.	up to 5 days
Secondary	Burden of AF	Burden of AF in the two groups (Day/Hours/minuts)	up to 5 days
Secondary	Number of patients with recurrent AF / atrial flutter / atrial tachycardia	Number of patients with recurrent AF / atrial flutter / atrial tachycardia in two groups	up to 5 days
Secondary	Total time of noise	Total time of noise in each group	up to 5 days
Secondary	Total time analized	Total time analized in each group	up to 5 days
Secondary	premature losses	loss of connection of the device before 5 days	up to 5 days
Secondary	time to analyze	time it takes to analyze and interpret the logs obtained, in minutes.	min:hours