PROSPective Evaluation of Outcome After CatheTer Ablation in Atrial Fibrillation

Overview

Atrial fibrillation ablation is the most common intervention performed worldwide. Up to 20 to 45% of patients show recurrence of AF within 12 month after catheter ablation, however its determinant are incompletely understood. The aim of the PROSPECT-AF study is to assess the predictors of AF recurrence within the 3 years following ablation using clinical variables and innovative biomarkers in a prospective cohort of 750 patients undergoing atrial fibrillation catheter ablation. The secondary aims are to assess the incidence of major adverse cardiovascular outcomes (MACE) and the incidence of major bleeding within the 3 years Wolfing catheter ablation.

Full Title of Study: “PROSPective Evaluation of Outcome After CatheTer Ablation in Atrial Fibrillation : LONGITUDINAL STUDY OF PATIENTS UNDERGOING RADIOFREQUENCY ABLATION OF ATRIAL FIBRILLATION.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2031

Interventions

  • Procedure: atrial fibrillation catheter ablation
    • The ablation is performed under local anesthesia or general anesthesia. A transseptal puncture will be performed to access the left atrium. Pulmonary vein isolation will be performed as a first step. Additional lesions will be made at the discretion of the operators. Patients will receive anticoagulation for at least 3 months after the ablation. Treatment thereafter will be extended at the discretion of the treating physician.

Arms, Groups and Cohorts

  • Patients undergoing atrial fibrillation catheter ablation
    • Patients undergoing scheduled atrial fibrillation catheter ablation.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of atrial fibrillation recurrence.
    • Time Frame: At 3 years

Secondary Measures

  • Incidence of major adverse cardiovascular events (MACE) including hospitalization for acute heart failure, cardiovascular death, stroke, myocardial infarction
    • Time Frame: At 3 years
  • Incidence of major bleeding (defined by BARC≥3 bleeding)
    • Time Frame: At 3 years

Participating in This Clinical Trial

Inclusion Criteria

  • Patient undergoing atrial fibrillation catheter ablation – Able to give their consent Exclusion Criteria:

  • Childs – Patient under guardianship – Patients unable to give their consent – Pregnancy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Lille
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sandro Ninni, MD, Principal Investigator, University Hospital, Lille
  • Overall Contact(s)
    • Sandro Ninni, MD, 0320445962, sandro.ninni@chru-lille.fr

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