NCT05009797

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Feb 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Feb 2023Feb 2031

First Submitted

Initial submission to the registry

August 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
1.5 years until next milestone

Study Start

First participant enrolled

February 16, 2023

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2031

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

8 years

First QC Date

August 16, 2021

Last Update Submit

April 21, 2026

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationCatheter ablationArrhythmiaBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Incidence of atrial fibrillation recurrence.

    At 3 years

Secondary Outcomes (2)

  • Incidence of major adverse cardiovascular events (MACE) including hospitalization for acute heart failure, cardiovascular death, stroke, myocardial infarction

    At 3 years

  • Incidence of major bleeding (defined by BARC≥3 bleeding)

    At 3 years

Study Arms (1)

Patients undergoing atrial fibrillation catheter ablation

Patients undergoing scheduled atrial fibrillation catheter ablation.

Procedure: atrial fibrillation catheter ablation

Interventions

atrial fibrillation catheter ablationPROCEDURE

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.

Patients undergoing atrial fibrillation catheter ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to the Lille University Hospital for schedulled Atrial fibrillation catheter ablation

You may qualify if:

  • Patient undergoing atrial fibrillation catheter ablation
  • Able to give their consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Coeur-Poumon, CHU

Lille, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Buffy coat, plasma, serum, PBMCs

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sandro Ninni, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandro Ninni, MD

CONTACT

0320445962sandro.ninni@chru-lille.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 18, 2021

Study Start

February 16, 2023

Primary Completion (Estimated)

February 1, 2031

Study Completion (Estimated)

February 1, 2031

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations

FR(1)