Contribution of Computed Tomography and Cardiac-MRI in Atrial Fibrillation Ablation

NCT04281329 | Recruiting

• 2 other identifiers: P150925JN° IDRCB : 2017-A03106-47
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Catheter ablation; Magnetic resonance imaging; Computed tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Comparaison of prognostic value of automated measurement of epicardial fat in CT and the references methods

  At 1 year

• Comparaison of volume and distribution of left atrial fat and total strail strain with data from electrophysiological mapping

  At 1 year

• Longitudinal study of subepicardial fat volume assessed by CT after ablation

  At 1 year

• Correlation between the fat volume and the biomarkers.

  At 1 year

Interventions

Magnetic resonance imaging PROCEDURE

Cardiac magnetic resonnance imaging before catheter ablation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients candidate for a first catheter ablation for atrial fibrillation

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• University Hospital, Bordeaux: collaborator
• Centre Cardiologique du Nord: collaborator

Study Sites (1)

Centre Hospitalier Universitaire Pitie-Salpetriere

Paris, 75013, France

RECRUITING

Related Publications (5)

• 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.

  PMID: 25727106 BACKGROUND

• 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.

  PMID: 24066158 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.

  PMID: 24496537 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.

  PMID: 26277495 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.

  PMID: 23525094 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Alban REDEHEUIL, MD, PhD

  Centre Hospitalier Universitaire Pitié-Salpêtrière Paris

  STUDY DIRECTOR

Central Study Contacts

Estelle GANDJBAKHCH, MD, PhD

CONTACT

01 42 16 30 55; estelle.gandjbakhch@aphp.fr

Hubert COCHET, MD, PhD

CONTACT

05 57 65 65 42; hcochet@wanadoo.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 24, 2020
• Study Start: April 1, 2022
• Primary Completion: April 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-04

Locations

FR (1)