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.
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.
France1 site, 1 recruiting
- 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
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
- Conditions
- Atrial Fibrillation
- 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.
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)
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
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
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
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.
- First posted24 Feb 2020
- Study start1 Apr 2022
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bordeaux, Centre Cardiologique du Nord
- Responsible party
- Sponsor
- Investigators
- Alban REDEHEUIL, MD, PhD, Study director, Centre Hospitalier Universitaire Pitié-Salpêtrière Paris
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 24496537Samanta 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 26277495Venteclef 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 23525094Akoum 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 25727106Chao 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
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT04281329
- Acronym / sponsor ID
- CTStrain-AF / P150925J
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Catheter ablation, Magnetic resonance imaging, Computed tomography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- University Hospital, Bordeaux, Centre Cardiologique du Nord
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients candidate for a first catheter ablation for atrial fibrillation
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imagingCardiac magnetic resonnance imaging before catheter ablation. | Procedure or surgery | – |
Primary outcome
Prognostic value of automated measurement of epicardial fat in CT and and total left atrial strain in MRI
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)
4 secondary outcomes
Comparaison of prognostic value of automated measurement of epicardial fat in CT and the references methods
Time frame: At 1 year
Comparaison of volume and distribution of left atrial fat and total strail strain with data from electrophysiological mapping
Time frame: At 1 year
Longitudinal study of subepicardial fat volume assessed by CT after ablation
Time frame: At 1 year
Correlation between the fat volume and the biomarkers.
Time frame: At 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Background: PubMed 24496537Marrouche 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.
- Background: PubMed 26277495Samanta 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.
- Background: PubMed 23525094Venteclef 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.
- Results publication: PubMed 25727106Akoum 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.
- Results publication: PubMed 24066158Chao 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.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alban REDEHEUIL, MD, PhD study director
Centre Hospitalier Universitaire Pitié-Salpêtrière Paris
1 site in 1 country: see every site and its status.
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.