Actively Recruiting
Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice
Led by Giulio Zucchelli · Updated on 2022-11-15
4100
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with an indication to an ablation procedure of Atrial Fibrillation according to current international and local guidelines, existing IFU, and physician discretion
- Patients willing and able to provide informed consent and participate in all testing at an approved clinical center
- Patients aged 18 years or older and legally able to give informed consent
You will not qualify if you...
- Patients enrolled in another investigational study or registry that interferes with this study, except mandatory governmental or purely observational registries
- Patients unwilling or unable to sign authorization to use and disclose health information or Informed Consent
- Patients unavailable or unwilling to complete study follow-up visits and examinations
- Life expectancy of 12 months or less as judged by physician
- Unresolved adverse events from any previous invasive procedure
- Women of childbearing potential who are or plan to become pregnant during the study
- Presence of left atrial thrombus on imaging within 4 weeks before ablation
- Atrial fibrillation caused by electrolyte imbalance, thyroid disease, or reversible non-cardiac causes
AI-Screening
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Trial Site Locations
Total: 1 location
1
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Actively Recruiting
Research Team
G
Giulio Zucchelli, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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