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RECRUITING
NCT05617456

Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice

Sponsor: Giulio Zucchelli

View on ClinicalTrials.gov

Summary

ATHENA is a prospective, multicenter, non-randomized post-market study. All patients will be treated according to the standard care followed by each center. The protocol requires enrollment of consecutive patients from each center, according to eligibility criteria. During the 12 months follow-up period, clinical atrial fibrillation recurrence, occurrence of all kind of atrial arrhythmias and of all Adverse Events in the study population will be collected. The purpose of this study is to prospectively evaluate during time a large population of patients with an indication for ablation of AF, collecting data on procedural success in the acute and medium- to long-term follow-up. The primary objective of the study is the determination of up to 20 clinical and procedural parameters predicting the recurrence-free at the medium-long term follow-up in consecutive patients undergoing atrial fibrillation ablation through a standard of care pathway. The success of the ablation is defined in terms of percentage of patients free from any clinical atrial arrhythmia at a 12-month follow-up from the procedure.

Official title: Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice: ATHENA Study

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

4100

Start Date

2022-01-01

Completion Date

2029-01

Last Updated

2022-11-15

Healthy Volunteers

No

Interventions

PROCEDURE

AF ablation

Patients with standard indications to AF ablation

Locations (1)

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy