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Atrial FibrillationCTStrain-AFNCT04281329

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

An observational study of Atrial Fibrillation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Magnetic resonance imaging
Type of treatment
Surgery or procedure
How many people
130 participants
Where
1 siteFrance
Study dates
1 Apr 2022to 1 Nov 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients candidate for a first catheter ablation for atrial fibrillation

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Estelle GANDJBAKHCH, MD, PhD contact

01 42 16 30 55 ext. + 33

estelle.gandjbakhch@aphp.fr

Hubert COCHET, MD, PhD contact

05 57 65 65 42 ext. + 33

hcochet@wanadoo.fr

France1 site, 1 recruiting
  • Centre Hospitalier Universitaire Pitie-Salpetriere

    Paris, 75013

    Estelle GANDJBAKHCH, Dh, 01 42 16 30 55, estelle.gandjbakhch@aphp.fr

    Hubert COCHET, Dh, 05 57 65 65 42, hcochet@wanadoo.fr

    Recruiting

Other trials in France

About this study

Official 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).

Read the detailed description

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:

  • To evaluate the clinical features associated with CT-measured atrial epicardial fat in patients requiring first AF ablation
  • To evaluate the clinical features associated with global and regional left atrial strain measured by MRI in patients who are candidates for first AF ablation
  • To study global and regional relationships between intramyocardial fat in CT and left atrial strain in MRI
  • To evaluate the impact of catheter ablation on the evolution of atrial subepicardial fat measured by CT
  • To evaluate the prognostic value of atrial subepicardial fat measured by CT after AF ablation
  • To evaluate the relation between subepicardial fat measured by CT and uni-and bipolar voltages mapped in sinus rhythm in patients who are candidates for first AF ablation
  • To evaluate the relationship between CT subcuticardic fatness and the distribution of AF-mapped fragmented electrograms in patients who are first-ablated with FA
  • To evaluate the relationship between segmental strain measured by MRI and uni and bipolar voltages mapped in sinus rhythm in patients who are candidates for first AF ablation
  • To evaluate the relationship between segmental strain measured by MRI and distribution of fragmented electrograms mapped to FA in patients who are candidates for first AF ablation.
  • To evaluate the interest of the cartographic fusion function-fat-function-electrophysiology 3D
  • To evaluate the relationship between epicardial fat measured by CT and serum biomarkers (adipokines: MMP8 and Activin A, ANF) measured at baseline and at 3 months after ablation
  • To evaluate the relationship between segmental strain measured by MRI and serum biomarkers (adipokines: MMP8 and Activin A, ANF) measured at baseline and at 3 months after ablation.

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)

  • Clinical examination, interrogation and antecedents;
  • ECG 12D;
  • Programming of the preoperative assessment: cardiac scanner after biological assessment with blood ionogram, urea and creatinine and cardiac ultrasound;
  • Verification of inclusion and non inclusion criteria;
  • Patient information and surrender of consent.

Inclusion visit V1 between the V0 selection visit and the maximum at D-1 before the ablation (J0), after collection of the consent

  • Cardiac MRI;
  • Biomarker assay and biological collection.
  • Recovery of Echocardiography, Standard Biological and Cardiac Scanner data prior to visit V2.

Visit V2: Ablation of FA = J0

  • Physical examination ;
  • ECG 12D;
  • Standard biological assessment;
  • Ablation data.

Follow-up visits:

  • V3 (M3 +/- 10d): Clinical examination, ECG 12D, holter ECG, cardiac scanner, standard biological assessment, biomarker assay and biological collection.
  • V4 (M6 +/- 15d): clinical examination, ECG 12D, holter ECG.
  • V5 (M12 +/- 1month) = End of study visit: Clinical examination, ECG 12D, holter ECG.

Number of selected subjects : 130 patients

Number of recruiting centers : 5 centers

Being tested
Magnetic resonance imaging
Keywords
Atrial fibrillation, Catheter ablation, Magnetic resonance imaging, Computed tomography
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic resonance imagingProcedure or surgery

    Cardiac magnetic resonnance imaging before catheter ablation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: At 1 year

Secondary outcomes (4)
  1. 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 .

    Measured: At 1 year

  2. 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

    Measured: At 1 year

  3. 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)

    Measured: At 1 year

  4. 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

    Measured: At 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2020
  2. Study start1 Apr 2022
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04281329
Sponsor's protocol ID
P150925J
Other IDs
N° IDRCB : 2017-A03106-47
Acronym
CTStrain-AF
Status last verified
Apr 2025
First submitted
20 Feb 2020
Last updated
6 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 24496537
  • 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.

    PubMed 26277495
  • 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.

    PubMed 23525094
  • 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.

    PubMed 25727106
  • 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.

    PubMed 24066158

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Estelle GANDJBAKHCH, MD, PhD (01 42 16 30 55 ext. + 33, estelle.gandjbakhch@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prognostic value of automated measurement of epicardial fat in CT and and total left atrial strain in MRI (time frame: At 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04281329, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.

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