NCT04281329 Contribution of Computed Tomography and Cardiac-MRI in Atrial Fibrillation Ablation
| NCT ID | NCT04281329 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 130 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 130 participants in total. It began in 2022-04-01 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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
Contact & Investigator
Alban REDEHEUIL, MD, PhD
STUDY DIRECTOR
Centre Hospitalier Universitaire Pitié-Salpêtrière Paris
Frequently Asked Questions
Who can join the NCT04281329 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04281329 currently recruiting?
Yes, NCT04281329 is actively recruiting participants. Contact the research team at estelle.gandjbakhch@aphp.fr for enrollment information.
Where is the NCT04281329 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04281329 clinical trial?
NCT04281329 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Alban REDEHEUIL, MD, PhD at Centre Hospitalier Universitaire Pitié-Salpêtrière Paris. The trial plans to enroll 130 participants.
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