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New mapping tech aims to improve heart ablation for AFib patients

NCT ID NCT06808217

Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This registry tracks 550 people with atrial fibrillation who are treated with the FARAPULSE pulsed field ablation system, using a special catheter and mapping technology. The goal is to see how safe and effective the procedure is in real-world settings over one year. Researchers will look at complications and how well the treatment controls the heart rhythm.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FARAPULSE Pulsed Field Ablation System (device)
What this could lead to
If successful, this could confirm that using the FARAPULSE system with advanced mapping improves safety and success rates for treating atrial fibrillation.
What could go wrong
This is an observational registry, not a randomized trial, so results may not prove cause and effect. Risks include procedure-related complications like bleeding or heart rhythm issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

550 people

The number who actually took part.

Started

Jul 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

• Subjects who will undergo an ablation procedure with the FARAPULSE™ Pulsed Field Ablation system, per physician's medical judgement, and according to hospitals' standard of care.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects are prospectively planned and intended to be treated with the FARAPULSE™ Pulsed Field Ablation system for cardiac tissue ablation, per physician's medical judgement, and as per hospitals' standard of care * Subjects who are willing and capable of providing informed consent * Subjects who are willing and capable of participating to this Registry at an approved clinical investigational center * Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law * Subjects are planned to undergo an ablation procedure whereby the FARAWAVE NAV PF Ablation Catheter is used in conjunction with the OPAL HDx Mapping System. Exclusion Criteria: * Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study. Exceptions are when the subject is participating in a mandatory governmental registry, or a purely observational registry, that do not interfere with the current study

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation Farapulse Pulsed field ablation

Contacts and locations

Locations

  • Allgemeines Krankenhaus AKH

    Vienna, Austria

  • Asklepios Klinik Saint Georg

    Hamburg, Germany

  • CHRU de Clermont-Ferrand

    Clermont-Ferrand, France

  • CHU Grenoble

    Grenoble, France

  • CHU de Saint-Etienne

    Saint-Priest-en-Jarez, France

  • Cardiocentro Ticino

    Lugano, Switzerland

  • Centre Cardiologique du Nord

    Saint-Denis, France

  • Centre Hospitalier Princesse Grace

    Monaco, Monaco

  • Clinica Montevergine

    Mercogliano, Italy

  • Clinique Pasteur

    Toulouse, France

  • Erasmus MC- University Medical Center

    Rotterdam, Netherlands

  • Henry Dunant Hospital Center

    Athens, Greece

  • Hospital Clinico San Carlos

    Madrid, Spain

  • Hospital Europeen Georges-Pompidou (HEGP)

    Paris, France

  • Hospital de Basurto

    Bilbao, Spain

  • Hospital de la Pitie-Salpetriere

    Paris, France

  • Ippokrateio General Hospital

    Thessaloniki, Greece

  • Isala Klinieken

    Zwolle, Netherlands

  • MVZ CCB Frankfurt und Main-Taunus GbR

    Frankfurt, Germany

  • Mater Private Hospital

    Dublin, Ireland

  • University Hospital Zurich

    Zurich, Switzerland

  • Vivantes Klinikum Am Urban

    Berlin, Germany

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