NCT01510210|Unknown
Risk Profile for Patients With Atrial Fibrillation
Identification of a Risk Profile to Guide Atrial Fibrillation Therapy
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Identification of a Risk Profile to Guide Atrial Fibrillation Therapy
Sponsor study identifier
observational
500
1 country
1
Study Start
April 2011
Actual (reported)Primary Completion
March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The objective of this study is to assess the risk profile in patients with atrial fibrillation, which represents the degree of changes in the atrial tissue and which can help predict in which patients rhythm control will be successful. This risk profile will consist of a combination of underlying (heart) disease and risk factors, measurements obtained from echocardiograms, and circulating biomarkers. Ultimately this risk profile can be used to guide type of rhythm control therapy in individual patients with atrial fibrillation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2011
Actual (reported)December 28, 2011
Actual (reported)January 16, 2012
Actual (reported)March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Success of rhythm control
(1) \< 1 second AF on end-of-study ECG; (2) \< 30 seconds AF on end-of-study 48-hour Holter recording; (3) no AF on end-of-study 2 weeks Vitaphone ECG-card recording.
12 month
Time to recurrence of (a)symptomatic AF
1+3+6+9+12 month
Failure of rhythm control, i.e. permanent AF
1+3+6+9+12 month
Risk profiles associated with early versus late AF recurrence
1month and 12 month
Progression of paroxysmal AF to persistent or permanent AF and of persistent AF to permanent AF
1+3+6+9+12 month
Changes in atrial and ventricular echocardiographic parameters
1month and 12 month
Patients with short-lasting symptomatic paroxysmal or persistent AF
University Medical Center Groningen
Groningen, 9713 GZ Groningen, Netherlands
De With RR, Artola Arita V, Nguyen BO, Linz D, Ten Cate H, Spronk H, Schotten U, van Zonneveld AJ, Erkuner O, Bayon MA, Schmidt AS, Luermans JGLM, Crijns HJGM, Van Gelder IC, Rienstra M. Different circulating biomarkers in women and men with paroxysmal atrial fibrillation: results from the AF-RISK and RACE V studies. Europace. 2022 Feb 2;24(2):193-201. doi: 10.1093/europace/euab179.
Nguyen BO, Meems LMG, van Faassen M, Crijns HJGM, van Gelder IC, Kuipers F, Rienstra M. Gut-microbe derived TMAO and its association with more progressed forms of AF: Results from the AF-RISK study. Int J Cardiol Heart Vasc. 2021 May 24;34:100798. doi: 10.1016/j.ijcha.2021.100798. eCollection 2021 Jun.
Serum and plasma stored at -80 degrees Celcius. If informed consent was obtained, DNA extraction has been performed.
Harry Crijns, MD PhD
Maastricht University Medical Center
Isabelle C Van Gelder, MD PhD
University Medical Center Groningen
500 participants (actual enrollment reported by the registry).
First Submitted
December 28, 2011
First Posted
January 16, 2012
Study Start
April 2011
Actual (reported)Multi-electrode PulmonarY Vein Isolation Versus Single Tip Wide Area Catheter Ablation for Paroxysmal Atrial Fibrillation (PAF)
Contact the study team to confirm eligibility.
De With RR, Marcos EG, Dudink EAMP, Spronk HM, Crijns HJGM, Rienstra M, Van Gelder IC. Atrial fibrillation progression risk factors and associated cardiovascular outcome in well-phenotyped patients: data from the AF-RISK study. Europace. 2020 Mar 1;22(3):352-360. doi: 10.1093/europace/euz339.
Primary Completion
March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 29, 2023
Record last verified: 2023-11
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