RESET-PFA 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 kinds 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 10 clinical and procedural parameters predicting a repeat ablation procedure after the blanking period in patients that had undergone an AF ablation with pulsed field ablation through a standard of care pathway.
Patients with an indication to a pulsed-field ablation procedure of Atrial Fibrillation according to current international and local guidelines (and future revisions), existing IFU or per physician discretion
Patients who are willing and capable of providing informed consent, participating in all testing at an approved clinical investigational center or such consent will be provided by a legal representative, if required by local law or regulation.
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.
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
Cohort
Prospective
Pulsed Field ablation: Ablation to treat atrial fibrillation
DevicePulsed Field Ablation
Title: Predictive Value of Procedural Workflow Parameters for Repeat Ablation
Association between specific procedural variables during the index procedure (e.g., number of PFA applications per vein, lesion validation method, total procedure time, voltage and activation map characteristics) as potential predictors of repeat ablation procedures and pulmonary vein isolation durability. Pulmonary vein isolation status will be assessed by electro-anatomical mapping systems in the repeat ablation procedure. The incidence of patients with isolated/not isolated pulmonary veins will be correlated with each procedural variable of the index procedure (number of PFA applications per vein, lesion validation method, total procedure time, voltage and activation map characteristics). All variables will be assessed individually and by multivariable logistic regression to establish odds ratio values.
Predictive Value of Baseline Clinical Characteristics for Repeat Ablation
Association individual baseline characteristics (e.g., age, sex, AF type, history of cardiac comorbidities, antiarrhythmic therapy) as potential predictors of repeat ablation procedures and pulmonary vein isolation durability. Pulmonary vein isolation status will be assessed by electro-anatomical mapping systems in the repeat ablation procedure. The incidence of patients with isolated/not isolated pulmonary veins will be correlated with baseline characteristics of the patient. All variables will be assessed individually and by multivariable logistic regression to establish odds ratio values.
Percentage of patients free from any clinical arrhythmia and use of Type I or Type III antiarrhythmic medication
Proportion (%) of patients with documented arrhythmias and the use of any Type I or Type III antiarrhythmic medication for the treatment of atrial fibrillation, atrial flutter, or atrial tachycardia occurring after the 8-week post-ablation blanking period. Arrhythmias include atrial fibrillation, atrial flutter, or atrial tachycardia episodes lasting \>30 seconds, detected by ECG, Holter monitor, or implantable loop recorder.
Rate of Repeat Ablation Procedure After Blanking Period
Proportion (%) of patients who undergo a repeat catheter ablation procedure for atrial arrhythmia recurrence occurring after the 8-week post-ablation blanking period. Arrhythmias include atrial fibrillation, atrial flutter, or atrial tachycardia episodes lasting \>30 seconds, detected by ECG, Holter monitor, or implantable loop recorder.
Durability of Pulmonary Vein Isolation at Repeat Procedure
Proportion of pulmonary veins (%) that remain durably isolated at the time of repeat ablation procedure due to atrial arrhythmia recurrence occurring after the 8-week post-ablation blanking period. Pulmonary veins isolation will be assessed by using high-density mapping.
Technical workflow variables of the PFA Procedure Over Time
This outcome aims at evaluating changes in technical periprocedural variables, such as total skin-to-skin time (from first puncture to final catheter withdrawal), catheter dwell time (from transeptal time to final catheter withdrawal), ablation time (from first PFA application to final PFA application) and fluoroscopy time (during the entire procedure) across the study period. Temporal milestones will be evaluated to reflect improvements in workflow efficiency as operator experience increases.
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