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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Patients with an indication to an ablation procedure of Atrial Fibrillation according to current international and local guidelines (and future revisions), existing IFU and per physician discretion

• Patients who are willing and capable of providing informed consent, participating in all testing at an approved clinical investigational center.

• Patients whose age is 18 years or above, and of legal age to give informed consent specific to state and national law.

Locations
Other Locations
Italy
Azienda Ospedaliero Universitaria Pisana
RECRUITING
Pisa
Contact Information
Primary
Giulio Zucchelli, MD, PhD
g.zucchelli@ao-pisa.toscana.it
+393283687691
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2029-01
Participants
Target number of participants: 4100
Related Therapeutic Areas
Sponsors
Leads: Giulio Zucchelli

This content was sourced from clinicaltrials.gov