Intracardiac Echocardiography-guided vs mapping-guided pulsed-field ablation for paroxysmal atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized trial conducted in selected European centers to compare two guidance strategies for pulsed-field ablation in paroxysmal AF. Participants will be randomized to ICE-guided catheter positioning or to electroanatomical mapping-guided ablation using the OPAL HDx system. The primary efficacy endpoint is freedom from atrial arrhythmia off antiarrhythmic drugs and without need for cardioversion or repeat ablation over 12 months; the primary safety endpoint is predefined adverse events. The study uses standard ablation with the FARAPULSE PFA system and analyzes whether guidance method impacts recurrence and safety. Enrollment requires planned ablation for paroxysmal AF and no major exclusion criteria are present beyond typical safety and renal/functional status requirements.

Why it matters

Who can join: the full rules

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

Where it's running

• Hygeia Hospital, 8th Cardiology Department
  Athens, Greece Recruiting
• University Hospital Centre Zagreb (KBC Zagreb)
  Zagreb, Croatia Not yet recruiting
• Department of Cardiology, IKEM
  Prague, Czechia Not yet 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

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• FARAFLEX Mapping and Pulsed Field Ablation for Atrial Fibrillation

  This trial tests the FARAFLEX Mapping and PFA System to see if it can safely help adults with drug-refractory paroxysmal or persistent atrial fibrillation.

  Recruiting at 13 sites Boston Scientific Corporation · Jonesboro, Arkansas and 12 other locations · NCT07575269

• Grid X mapping for paroxysmal atrial fibrillation

  This study will try the Grid X catheter together with the EnSite X mapping system during catheter ablation to see if it helps Chinese adults with paroxysmal atrial fibrillation.

  Recruiting at 5 sites Abbott Medical Devices · Jinan, Shandong and 4 other locations · NCT07421076

• Redo AF ablation using the Sphere-9 catheter and Affera system for recurrent paroxysmal and persistent atrial fibrillation

  The study will try the Sphere-9 catheter with the Affera ablation and mapping systems for adults who have symptomatic recurrent paroxysmal or persistent atrial fibrillation after one prior ablation.

  Recruiting at 24 sites Medtronic Cardiac Ablation Solutions · Birmingham, Alabama and 29 other locations · NCT07298473

• Pulmonary vein isolation plus box isolation of fibrotic areas using the Globe pulsed field system for symptomatic paroxysmal or persistent atrial fibrillation

  This trial will test whether using the Globe pulsed field system to perform pulmonary vein isolation plus box isolation of fibrotic areas helps people with symptomatic paroxysmal or persistent atrial fibrillation stay free of arrhythmia over 12 months.

  Recruiting Kardium Inc. · Kaiserslautern · NCT06973031

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.