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

NCT07772518 | Recruiting DMC

• 1 other identifier: 25-06-2026 677
• Study Type: interventional
• Target: 292
• Locations: 7 countries
• Sites: 7

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.

Conditions

Paroxysmal Atrial Fibrillation (PAF)

Keywords

atrial fibrillation; paroxysmal atrial fibrillation; intracardiac echocardiography; ICE; FARAVIEW; pulsed field ablation

Outcome Measures

Primary Outcomes (2)

• Arrhythmia-free survival

  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

  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 Outcomes (6)

• Arrhythmia-free survial (>30 sec)

  up to 12 months

• Procedure time (min)

  Periprocedural

• Left atrial dwell time (min)

  Periprocedural

• Number of lesions

  Periprocedural

• Fluoroscopy time (min)

  Periprocedural

Study Arms (2)

ICE

OTHER

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.

Mapping

OTHER

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.

Interventions

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.

ICE; Mapping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of paroxysmal AF.
• Scheduled to undergo AF catheter ablation with the FARAPULSE (Boston Scientific) PFA system.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mitera Hospital: lead

Study Sites (8)

University Hospital Centre Zagreb (KBC Zagreb)

Zagreb, Croatia

NOT YET RECRUITING

Department of Cardiology, IKEM

Prague, Czechia

NOT YET RECRUITING

Hygeia Hospital, 8th Cardiology Department

Athens, Greece

RECRUITING

Heart and Vascular Center, Semmelweis University

Budapest, Hungary

NOT YET RECRUITING

Marche Polytechnic University / Marche University Hospital

Ancona, Italy

NOT YET RECRUITING

Grochowski Hospital, Centre of Postgraduate Medical Education

Warsaw, Poland

NOT YET RECRUITING

Department of Arrhythmology, Institute of Cardiovascular Diseases

Banská Bystrica, Slovakia

NOT YET RECRUITING

University Medical Centre Ljubljana (UKC Ljubljana)

Ljubljana, Slovenia

NOT YET RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Patient Positioning

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Stylianos Tzeis, MD, PhD, FEHRA

CONTACT

+302106869777; steis@otenet.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology Department, Mitera Hospital, Hygeia Group, Athens, Greece

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 19, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 19, 2026

Record last verified: 2026-08

Locations

HU (1); CR (1); SL (1); CZ (1); IT (1); GR (1); PL (1)