Centre Hospitalier Universitaire Pitie-Salpetriere
Paris, 75013, France
Location status: Recruiting
Location contact
Estelle GANDJBAKHCH, Dh
CONTACT
Hubert COCHET, Dh
CONTACT
NCT Number: NCT04281329
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Paris, 75013, France
Location status: Recruiting
Estelle GANDJBAKHCH, Dh
CONTACT
Hubert COCHET, Dh
CONTACT
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
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cardiac magnetic resonnance imaging before catheter ablation.
Time frame: At 1 year
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)
Time frame: At 1 year
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 .
Time frame: At 1 year
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
Time frame: At 1 year
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)
Time frame: At 1 year
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
Contact information is provided by the study sponsor or research team.
Estelle GANDJBAKHCH, MD, PhD
CONTACT
01 42 16 30 55 ext. + 33
Hubert COCHET, MD, PhD
CONTACT
05 57 65 65 42 ext. + 33
Assistance Publique - Hôpitaux de Paris
Other
Contribution of Left Atrial Epicardial Fat Quantification by Computed Tomography and Left Atrial Strain by MRI in Atrial-Fibrilation Ablation: "The CTStrain-AF Study"
Acronym: CTStrain-AF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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