Paroxysmal Atrial Fibrillation (PAF)
Conditions
Keywords
atrial fibrillation, paroxysmal atrial fibrillation, intracardiac echocardiography, ICE, FARAVIEW, pulsed field ablation
Brief summary
This is a prospective, randomized clinical trial, which will be conducted in selected European centers. The objective is to compare two commonly used strategies to guide pulsed-field ablation (PFA) in patients with paroxysmal atrial fibrillation (AF). Patients with paroxysmal AF planned to undergo PFA will be randomized to intracardiac echocardiography (ICE)-guided or electroanatomical mapping-guided (OPAL HDx mapping system) ablation procedure. The primary efficacy endpoint will be freedom from atrial arrhythmia (AF, atrial flutter, atrial tachycardia) recurrence off antiarrhythmic drug therapy and without the need for electrical cardioversion or repeat ablation, with a follow-up duration of 12 months. The primary safety endpoint will be the incidence of predefined safety outcomes.
Interventions
OTHERIn the ICE group, positioning/contact of the ablation catheter will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping.
Ablation procedure (electrical isolation of the pulmonary veins) will be performed according to routine clinical practice. In the ICE group, positioning of the ablation catheter and confirmation of contact with the targeted tissue will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping with the FARAVIEW system (OPAL HDx, software version 7.0, Boston Scientific). PFA will be delivered using field-tag feature ensuring number of applications and stacking as suggested by IFU. In the mapping group, the use of ICE will only be allowed to guide the transseptal puncture in order to ensure procedural safety in both groups.
Sponsors
Mitera Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of paroxysmal AF. * Scheduled to undergo AF catheter ablation with the FARAPULSE (Boston Scientific) PFA system.
Exclusion criteria
* Any contraindication to AF catheter ablation. * History of previous left atrial ablation. * Need for additional ablation beyond pulmonary vein isolation. * Inability to provide written informed consent. * Any factor that, in the investigator's judgment, renders the patient unsuitable for participation or may compromise their safety. * eGFR \< 30 mL/min/1.73 m2 * NYHA class III/IV heart failure * Major cardiovascular events within 90 days * Secondary AF owing to reversible causes * Intracardiac thrombus or other conditions making left atrial instrumentation unsafe * Severe valvular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arrhythmia-free survival | up to 12 months | Primary efficacy endpoint: Number of patients without atrial arrhythmia recurrence (AF, atrial flutter, atrial tachycardia) off antiarrhythmic drug therapy and without the need for electrical cardioversion or repeat ablation, after a blanking period of 2 months. A recurrence is defined as any episode of atrial tachyarrhythmia recorded on standard 12-lead ECG or any episode lasting ≥6 minutes on Holter monitor (or CIED with atrial sensing capabilities). |
| Complications | up to 12 months | Composite primary safety endpoint: Number of participants experiencing at least one of the following prespecified complications (major safety events): Stroke, transient ischemic attack, or systemic embolism Coronary spasm Myocardial infarction Cardiac tamponade Clinically relevant esophageal complication Clinically relevant pulmonary vein stenosis Diaphragmatic paralysis persisting for more than 6 months Acute kidney injury Bleeding requiring transfusion Major vascular complication Pericarditis or vagal nerve injury Heart failure or pulmonary edema Sudden death within 30 days of the procedure Any device- or procedure-related death For the composite primary safety endpoint, each participant will be counted only once, regardless of the number or type of qualifying events experienced. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arrhythmia-free survial (>30 sec) | up to 12 months | Number of patients without atrial arrhythmia recurrence (AF, atrial flutter, atrial tachycardia) lasting \>30 seconds on Holter monitoring, off antiarrhythmic drug therapy and without the need for electrical cardioversion or repeat ablation, after an initial blanking period of 2 months. |
| Procedure time (min) | Periprocedural | Time from femoral puncture to catheter removal (minutes). |
| Left atrial dwell time (min) | Periprocedural | Time from transseptal puncture to catheter withdrawal from the left atrium (minutes). |
| Number of lesions | Periprocedural | Total number of ablation lesions deployed. |
| Fluoroscopy time (min) | Periprocedural | Duration of fluoroscopy (minutes). |
| Fluoroscopy dose (cGy·cm²) | Periprocedural | Total fluoroscopy dose (measured in cGy·cm²). |
Countries
Croatia, Czechia, Greece, Hungary, Italy, Poland, Slovakia, Slovenia
Contacts
CONTACTStylianos Tzeis, MD, PhD, FEHRA
Outcome results
None listed