PROSPective Evaluation of Outcome After CatheTer Ablation in Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— PROSPECT-AF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05009797
• Other study ID #: 2018_83
• Secondary ID: 2020-A02171-38
• Status: Recruiting
• Start date: February 16, 2023
• Est. completion date: February 2031

Study information

• Verified date: February 2023
• Source: University Hospital, Lille
• Contact: Sandro Ninni, MD
• Phone: 0320445962
• Email: sandro.ninni[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: February 2031
• Est. primary completion date: February 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
France	Institut Coeur-Poumon, CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of atrial fibrillation recurrence.		At 3 years
Secondary	Incidence of major adverse cardiovascular events (MACE) including hospitalization for acute heart failure, cardiovascular death, stroke, myocardial infarction		At 3 years
Secondary	Incidence of major bleeding (defined by BARC=3 bleeding)		At 3 years