Atrial Fibrillation Clinical Trial
— CTStrain-AFOfficial title:
Contribution of Left Atrial Epicardial Fat Quantification by Computed Tomography and Left Atrial Strain by MRI in Atrial-Fibrilation Ablation: "The CTStrain-AF Study"
Atrial fibrillation ablation (AF) is a standard interventional treatment for patients with symptomatic AF refractory to medical treatment. The known predictive factors for the success of the procedure remain insufficient to predict the probabilities of success and to appropriately select the patients who could benefit the most from this procedure. Left atrium imaging by MRI or CT may be able to identify AF substrate. However data are lacking about the practical impact of these techniques in routine practice to predict AF ablation outcome. The "CT-AF" study is a prospective, interventional, multicenter cohort study. The main objective of this study is to evaluate the prognostic value of a new automated measurement technique for intra-myocardial atrial fat measurement in cardiac CT and the measurement of global left atrial strain in MRI in patients who are candidates for first AF ablation. The main outcome will be the relationship between the relative volume of left atrial fat measured with CT and total left atrial strain in MRI and recurrence of AF at 1 year after the ablation procedure (blanking period of 3 months post ablation excluded).
Status | Recruiting |
Enrollment | 130 |
Est. completion date | November 1, 2025 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient in whom radiofrequency AF ablation is scheduled within the next 6 months. - age =18 years - Patient affiliated to a social security scheme - Patient informed and given written consent for participation in the study. Exclusion Criteria: - Refusal to participate in the study - Patient who has already benefited from an AF ablation procedure - Patient for whom an AF ablation procedure by cryoablation system is planned - Scanner or MRI pre-inclusion not exploitable - Presence of an implantable cardiac prosthesis of pacemaker type or defibrillator - Claustrophobia - Iodinated / gadolinium contrast medium allergy - Chronic renal failure with clearance <30ml / min - Follow-up visits not possible - Pregnancy in progress - Patients unable to sign consent - Minors and adults protected under legal protection (tutorship or guardianship) - Period of exclusion from a research study |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Universitaire Pitie-Salpetriere | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Centre Cardiologique du Nord, University Hospital, Bordeaux |
France,
Akoum N, Wilber D, Hindricks G, Jais P, Cates J, Marchlinski F, Kholmovski E, Burgon N, Hu N, Mont L, Deneke T, Duytschaever M, Neumann T, Mansour M, Mahnkopf C, Hutchinson M, Herweg B, Daoud E, Wissner E, Brachmann J, Marrouche NF. MRI Assessment of Abla — View Citation
Chao TF, Hung CL, Tsao HM, Lin YJ, Yun CH, Lai YH, Chang SL, Lo LW, Hu YF, Tuan TC, Chang HY, Kuo JY, Yeh HI, Wu TJ, Hsieh MH, Yu WC, Chen SA. Epicardial adipose tissue thickness and ablation outcome of atrial fibrillation. PLoS One. 2013 Sep 16;8(9):e749 — View Citation
Marrouche NF, Wilber D, Hindricks G, Jais P, Akoum N, Marchlinski F, Kholmovski E, Burgon N, Hu N, Mont L, Deneke T, Duytschaever M, Neumann T, Mansour M, Mahnkopf C, Herweg B, Daoud E, Wissner E, Bansmann P, Brachmann J. Association of atrial tissue fibrosis identified by delayed enhancement MRI and atrial fibrillation catheter ablation: the DECAAF study. JAMA. 2014 Feb 5;311(5):498-506. doi: 10.1001/jama.2014.3. Erratum in: JAMA. 2014 Nov 5;312(17):1805. — View Citation
Samanta R, Pouliopoulos J, Thiagalingam A, Kovoor P. Role of adipose tissue in the pathogenesis of cardiac arrhythmias. Heart Rhythm. 2016 Jan;13(1):311-20. doi: 10.1016/j.hrthm.2015.08.016. Epub 2015 Aug 12. Review. — View Citation
Venteclef N, Guglielmi V, Balse E, Gaborit B, Cotillard A, Atassi F, Amour J, Leprince P, Dutour A, Clément K, Hatem SN. Human epicardial adipose tissue induces fibrosis of the atrial myocardium through the secretion of adipo-fibrokines. Eur Heart J. 2015 Apr 1;36(13):795-805a. doi: 10.1093/eurheartj/eht099. Epub 2013 Mar 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prognostic value of automated measurement of epicardial fat in CT and and total left atrial strain in MRI | Relationship between the relative volume of left atrial fat and total left atrial strain in MRI and recurrence of atrial rhythm disturbances (defined as sustained atrial rhythm disturbance> 30 seconds) at 1 year after the ablation procedure (blanking period of 3 months post ablation excluded) | At 1 year | |
Secondary | Comparaison of prognostic value of automated measurement of epicardial fat in CT and the references methods | Comparison of the prognostic value of automated measurement of epicardial fat in CT compared to two reference methods (manual measurement of the reference literature) in all patients . | At 1 year | |
Secondary | Comparaison of volume and distribution of left atrial fat and total strail strain with data from electrophysiological mapping | Global and regional comparison of the relative volume of left atrial fat assessed by CT and left atrial strain assessed by MRI with electroanatomical mapping (voltage and fragmented potential maps) time frame: at one year | At 1 year | |
Secondary | Longitudinal study of subepicardial fat volume assessed by CT after ablation | Comparison of subepicardial left atrial fat volume assessed by CT before and after ablation and prognosis value of the post-ablation subepicardial fat volume on ablation success rate at one year (blanking period of 3 months excluded) | At 1 year | |
Secondary | Correlation between the fat volume and the biomarkers. | The correlation between left atrial fat vollume assessed by CT or left atrial strain assessed by MRI with biomarkers (adipokines: MMP8 and Activin A, ANF) will be studied at baseline and 3 months post ablation. The prognosis value of biomarkers with the ablation success rate at one year (blanking period of 3 months post ablation) will be studied | At 1 year |
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