Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorGiulio Zucchelli
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments
Patients who are unwilling or unable to sign an authorization to use and disclose health information or an Informed Consent.
Patients unavailable or not willing to complete follow up visits and examination for the duration of the study at the center.
Life expectancy ≤ 12 months per physician judgment.
Trial population
All consecutive patients, clinically indicated for AF ablation, will be enrolled after signing an informed consent form and an authorization to use and disclose health information
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
AF ablation
Procedure/SurgeryPatients with standard indications to AF ablation
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Baseline patient's characteristic (clinical history and drug therapy) and procedural measures for subjects undergoing catheter ablation
The primary outcome of this study measures the baseline patient's characteristics (clinical history and drug therapy) and electro-anatomical variables derived from the ablation approach (e.g. evaluation of voltage and activation maps, lesion validation, procedural workflow) as potential predictors of documented atrial arrhythmias, that will be evaluated at 12 months. Arrhythmias in the definition are any AF, atrial flutter, or atrial tachycardia episode, continuous for \>30 seconds, as recorded by any post-ablation ECG modality. Arrhythmia recurrences within the first 3 months (blanking period) are classified as early recurrences and will not be considered procedural failure
Time frame
12 monthsSecondary outcomes
1
Acute procedural success of AF ablation
This secondary outcome measures the percentage of acute procedural success. The acute success of the AF ablation is verified by: the completion of the necessary ablation application(s), the validation of ablation through appropriate technique(s) and, when applicable, the termination of the primary arrhythmia.
Time frame
within 30 minutes after ablation procedure2
Number and percentage of patients with clinical atrial arrhythmia recurrences in the mid-term
This secondary outcome is to measure the percentage of patients with documented arrhythmias after 12- months from the procedure
Time frame
12 months3
Number and percentage of patients with clinical atrial arrhythmia recurrences in the long- and very long- term
This secondary outcome is to measure the percentage of patients with documented arrhythmias after 24-, 36- and 60- months from the procedure
Time frame
60 months4
Procedural ablation parameters
This secondary outcome measures the radiofrequency delivery time, the total ablation time, the fluoroscopy time, acquisition time, number of points per map, cardiac area and volume acquired from the maps
Time frame
IntraoperativeSponsors and contacts
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Giulio Zucchelli
Lead sponsor
Azienda Ospedaliero, Universitaria Pisana
Sponsor institution
Source ClinicalTrials.gov