Intracardiac Echocardiography-guided Versus Electroanatomical Mapping-guided Pulsed Field Ablation for Paroxysmal Atrial Fibrillation (PFA-VISION)

August 13, 2026 updated by: Stylianos Tzeis, Mitera Hospital

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

292

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Stylianos Tzeis, MD, PhD, FEHRA
  • Phone Number: +302106869777
  • Email: steis@otenet.gr

Study Locations

  • Croatia
      • Zagreb, Croatia
        • Not yet recruiting
        • University Hospital Centre Zagreb (KBC Zagreb)
        • Contact:
  • Czechia
      • Prague, Czechia
        • Not yet recruiting
        • Department of Cardiology, IKEM
        • Contact:
  • Greece
      • Athens, Greece
        • Recruiting
        • Hygeia Hospital, 8th Cardiology Department
        • Contact:
          • Stylianos Tzeis, MD, PhD, FEHRA
          • Phone Number: +302106869777
          • Email: stzeis@otenet.gr
  • Hungary
      • Budapest, Hungary
        • Not yet recruiting
        • Heart and Vascular Center, Semmelweis University
        • Contact:
  • Italy
      • Ancona, Italy
        • Not yet recruiting
        • Marche Polytechnic University / Marche University Hospital
        • Contact:
  • Poland
      • Warsaw, Poland
        • Not yet recruiting
        • Grochowski Hospital, Centre of Postgraduate Medical Education
        • Contact:
  • Slovakia
      • Banská Bystrica, Slovakia
        • Not yet recruiting
        • Department of Arrhythmology, Institute of Cardiovascular Diseases
        • Contact:
  • Slovenia
      • Ljubljana, Slovenia
        • Not yet recruiting
        • University Medical Centre Ljubljana (UKC Ljubljana)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ICE
Intracardiac echocardiography-guided group
Other: 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.
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.
Other: Mapping
Three-dimensional electroanatomical mapping-guided group
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
up to 12 months
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.
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 12 months
Procedure time (min)
Time Frame: Periprocedural
Time from femoral puncture to catheter removal (minutes).
Periprocedural
Left atrial dwell time (min)
Time Frame: Periprocedural
Time from transseptal puncture to catheter withdrawal from the left atrium (minutes).
Periprocedural
Number of lesions
Time Frame: Periprocedural
Total number of ablation lesions deployed.
Periprocedural
Fluoroscopy time (min)
Time Frame: Periprocedural
Duration of fluoroscopy (minutes).
Periprocedural
Fluoroscopy dose (cGy·cm²)
Time Frame: Periprocedural
Total fluoroscopy dose (measured in cGy·cm²).
Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitera Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

August 10, 2026

First Submitted That Met QC Criteria

August 13, 2026

First Posted (Actual)

August 19, 2026

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-06-2026 677

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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