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| ID | Type | Description | Link |
|---|---|---|---|
| N° IDRCB : 2017-A03106-47 | Other Identifier | National Agency for the Safety of Medicines |
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| Name | Class |
|---|---|
| University Hospital, Bordeaux | OTHER |
| Centre Cardiologique du Nord | OTHER |
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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).
Scientific background :
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 invasive procedure. Previous studies have shown that the quantification of atrial fibrosis in magnetic resonance imaging (MRI) may be a good marker of atrial remodeling and would reliably predict the chances of success of the ablation procedure. Nevertheless, the use of this technique is very limited in routine because of the complexity of quantitative analysis and spatial resolution limits. The association of fibrosing processes within epicardial fat has been established. The characterization of epicardial fat in CT could be a relevant substitute for the direct characterization of fibrosis. This examination was essential for the study of atrial anatomy before ablation of AF. In addition to the anatomical evaluation, the study of sub-epicardial fat by cardiac CT could therefore be an interesting approach for evaluating the AF substrate.
Main objective:
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.
Secondary objectives:
Experimental scheme:
This is a prospective, interventional, multicenter cohort study. Patients with a first radiofrequency or cryotherapy AF ablation are expected to receive a cardiac CT scan (performed for left atrial anatomy study) from which the volume of sub-epicardial fat will be measured. by a new automated measurement technique. The correlation of this measure with the success of ablation (defined as the absence of recurrence of atrial arrhythmia sustained> 30 seconds) will be blinded prospectively to 1 year of follow-up. In addition, the reliability of this measurement will be validated against reference measurements in CT and MRI. The evolution of epicardial fat volume after ablation will be evaluated by a control scan performed as part of the treatment (detection of FA post-ablation pulmonary stenosis). The methods of overall care, imaging examinations and decision criteria at the level of care are common to the 3 investigative centers.
Visits:
V0: selection visit between M-6 and J-1 before ablation (J0)
Inclusion visit V1 between the V0 selection visit and the maximum at D-1 before the ablation (J0), after collection of the consent
Visit V2: Ablation of FA = J0
Follow-up visits:
Number of selected subjects : 130 patients
Number of recruiting centers : 5 centers
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic resonance imaging | Procedure | Cardiac magnetic resonnance imaging before catheter ablation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Comparaison of volume and distribution of left atrial fat and total strail strain with data from electrophysiological mapping |
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Inclusion Criteria:
Exclusion Criteria:
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Patients candidate for a first catheter ablation for atrial fibrillation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Estelle GANDJBAKHCH, MD, PhD | Contact | 01 42 16 30 55 | + 33 | estelle.gandjbakhch@aphp.fr |
| Hubert COCHET, MD, PhD | Contact | 05 57 65 65 42 | + 33 | hcochet@wanadoo.fr |
| Name | Affiliation | Role |
|---|---|---|
| Alban REDEHEUIL, MD, PhD | Centre Hospitalier Universitaire Pitié-Salpêtrière Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Pitie-Salpetriere | Recruiting | Paris | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24496537 | Background | 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. | |
| 26277495 |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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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 |
| 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 |
| 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 |
| Background |
| 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. |
| 23525094 | Background | Venteclef N, Guglielmi V, Balse E, Gaborit B, Cotillard A, Atassi F, Amour J, Leprince P, Dutour A, Clement 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. |
| 25727106 | Result | 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 Ablation-Induced Scarring in Atrial Fibrillation: Analysis from the DECAAF Study. J Cardiovasc Electrophysiol. 2015 May;26(5):473-80. doi: 10.1111/jce.12650. Epub 2015 Apr 23. |
| 24066158 | Result | 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):e74926. doi: 10.1371/journal.pone.0074926. eCollection 2013. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |