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PROSPective Evaluation of Outcome After CatheTer Ablation in Atrial Fibrillation

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05009797
Acronym
PROSPECT-AF
Enrollment
750
Registered
2021-08-18
Start date
2023-02-16
Completion date
2031-02-28
Last updated
2025-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, Catheter ablation, Arrhythmia, Biomarkers

Brief summary

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

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.

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence of atrial fibrillation recurrence.At 3 years

Secondary

MeasureTime frame
Incidence of major adverse cardiovascular events (MACE) including hospitalization for acute heart failure, cardiovascular death, stroke, myocardial infarctionAt 3 years
Incidence of major bleeding (defined by BARC≥3 bleeding)At 3 years

Countries

France

Contacts

Primary ContactSandro Ninni, MD
sandro.ninni@chru-lille.fr0320445962

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026