CLARITY: ECG Monitoring Short vs Middle Term After Atrial Fibrillation Ablation
Sponsor
Hospital Clinic of Barcelona (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05959915
Collaborator
(none)
96
1
15
6.4
Study Details
Study Description
Brief Summary
To compare the number of patients with AF recurrence detected in a 24-h Holter monitoring with a 5-day record.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
96 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
ECG Monitoring Short vs Middle Term After Atrial Fibrillation Ablation
Actual Study Start Date
:
Jul 1, 2023
Anticipated Primary Completion Date
:
Jul 1, 2024
Anticipated Study Completion Date
:
Oct 1, 2024
Outcome Measures
Primary Outcome Measures
- AF recurrence [5-days]
Number of patients with AF recurrence detected in a 24-h Holter monitoring.
Secondary Outcome Measures
- Adverse effects [5-days]
- Burden of AF [5-days]
Burden of AF in the two groups (Day/Hours/minuts)
- Number of patients with recurrent AF / atrial flutter / atrial tachycardia [5-day]
Number of patients with recurrent AF / atrial flutter / atrial tachycardia in two groups
- Total time of noise [5-day]
Total time of noise in each group
- Total time analized [5-day]
Total time analized in each group
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 99 Years
Sexes Eligible for Study:
All
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Clínic Barcelona | Barcelona | Spain | 08036 |
Sponsors and Collaborators
- Hospital Clinic of Barcelona
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Responsible Party:
Josep Lluis Mont Girbau,
Head of AF Unit,
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT05959915
Other Study ID Numbers:
- CLARITY
First Posted:
Jul 25, 2023
Last Update Posted:
Jul 25, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms: