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NCT Number: NCT07772518

Intracardiac Echocardiography-guided Versus Electroanatomical Mapping-guided Pulsed Field Ablation for Paroxysmal Atrial Fibrillation

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.

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Key information

Conditions

Paroxysmal Atrial Fibrillation (PAF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Centre Zagreb (KBC Zagreb), Zagreb, Croatia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

In 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.

Other

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.

Primary outcomes

  1. Arrhythmia-free survival

    Time frame: 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).

  2. Complications

    Time frame: 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 outcomes

  1. Arrhythmia-free survial (>30 sec)

    Time frame: 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.

  2. Procedure time (min)

    Time frame: Periprocedural

    Time from femoral puncture to catheter removal (minutes).

  3. Left atrial dwell time (min)

    Time frame: Periprocedural

    Time from transseptal puncture to catheter withdrawal from the left atrium (minutes).

  4. Number of lesions

    Time frame: Periprocedural

    Total number of ablation lesions deployed.

  5. Fluoroscopy time (min)

    Time frame: Periprocedural

    Duration of fluoroscopy (minutes).

  6. Fluoroscopy dose (cGy·cm²)

    Time frame: Periprocedural

    Total fluoroscopy dose (measured in cGy·cm²).

Study contacts

Contact information is provided by the study sponsor or research team.

Stylianos Tzeis, MD, PhD, FEHRA

CONTACT

[email protected]

+302106869777

Sponsors and collaborators

Lead sponsor

Mitera Hospital

Other

Registry information

Official study title

Intracardiac Echocardiography-guided Versus Electroanatomical Mapping-guided Pulsed Field Ablation for Paroxysmal Atrial Fibrillation - the PFA-VISION Randomized Trial (Pulsed Field Ablation - Visualization and Imaging Strategies for Isolation Outcomes in Paroxysmal Atrial fibrillatioN)

Acronym: PFA-VISION

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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