PROSPective Evaluation of Outcome After CatheTer Ablation in Atrial Fibrillation

NCT ID: NCT05009797

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-16

Study Completion Date

2031-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing atrial fibrillation catheter ablation

Patients undergoing scheduled atrial fibrillation catheter ablation.

atrial fibrillation catheter ablation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandro Ninni, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Institut Coeur-Poumon, CHU

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sandro Ninni, MD

Role: CONTACT

0320445962 ext. +33

Other Identifiers

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2020-A02171-38

Identifier Type: OTHER

Identifier Source: secondary_id

2018_83

Identifier Type: -

Identifier Source: org_study_id

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