PROSPective Evaluation of Outcome After CatheTer Ablation in Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: atrial fibrillation catheter ablation.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PROSPective Evaluation of Outcome After CatheTer Ablation in Atrial Fibrillation : LONGITUDINAL STUDY OF PATIENTS UNDERGOING RADIOFREQUENCY ABLATION OF 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.
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.
Primary outcome measures
- Incidence of atrial fibrillation recurrence. [Time frame: At 3 years]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Institut Coeur-Poumon, CHU — Lille
Identifiers
NCT: NCT05009797 · 2018_83 · 2020-A02171-38