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New heart device aims to zap away irregular rhythm

NCT ID NCT05501873

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 20, 2026 · Updated 4 times

Summary

This study is tracking over 1,100 people with atrial fibrillation who are treated with the FARAPULSE system, a device that uses electrical pulses to destroy tiny areas of heart tissue causing the irregular rhythm. The goal is to see how well it works and how safe it is in everyday hospital use. Researchers will check if patients stay in normal rhythm for at least 12 months after the procedure.

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 (a device that uses electrical pulses to destroy abnormal heart tissue)
What this could lead to
If successful, this could confirm that pulsed field ablation is a safe and effective way to treat atrial fibrillation and restore normal heart rhythm.
What could go wrong
This is an observational registry, not a controlled trial, so results may be less definitive. Risks include device- or procedure-related serious side effects, and long-term benefits are still being studied.

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

1,173 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Aug 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 enrolled in the FARADISE study will be clinically indicated for an ablation procedure with the FARAPULSE™ Pulsed Field Ablation system, per physician's medical judgement, and according to the 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: 1. Subjects 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 2. Subjects who are willing and capable of providing informed consent 3. Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center 4. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law Exclusion Criteria: 1. Subjects with a current interatrial baffle or patch 2. Subjects with a known or suspected atrial myxoma 3. Subjects with a myocardial infarction within 14 days prior to enrollment 4. Subjects with a recent (within 30 days prior to enrollment) Cerebral Vascular Accident (CVA) 5. Subjects who do not tolerate anticoagulation therapy 6. Subjects with an active systemic infection \* 7. Subjects with a presence of atrial known thrombus \* 8. Subjects with a known inability to obtain vascular access 9. Subjects who are pregnant or planning to be pregnant 10. Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes 11. Subjects with any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty 12. Subjects with a contraindication to an invasive electrophysiology procedure where insertion or manipulation of a catheter in the cardiac chambers is deemed unsafe per physician's medical judgement, such as, but not limited to, a recent previous cardiac surgery (eg. ventriculotomy or atriotomy, CABG, PTCA/PCI/coronary stent procedure/unstable angina) and/or in patients with congenital heart disease where the underlying abnormality increases the risk of the ablation (e.g., severe rotational anomalies of the heart or great vessels) 13. Subjects with a life expectancy of ≤ 1 year per investigator's opinion 14. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility

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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

Contacts and locations

Locations

  • AZ Sint Jan Hospital

    Bruges, Belgium

  • Allgemeines Krankenhaus AKH

    Vienna, Austria

  • Az. Osp. Lancisi-Hospital

    Ancona, Italy

  • CHR de la Citadelle

    Liège, Belgium

  • CHU Grenoble

    Grenoble, France

  • Casa Di Cura 'Montevergine' S.P.A.

    Mercogliano, Italy

  • Catharina Ziekenhuis

    Eindhoven, Netherlands

  • Centre Cardiologique du Nord

    Saint-Denis, France

  • Centro Especial Ramon y Cajal

    Madrid, Spain

  • Clinica Universidad de Navarra

    Pamplona, Spain

  • Clinique Ambroise Pare-Hospital

    Neuilly, France

  • Clinique Pasteur Toulouse

    Toulouse, France

  • Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH

    Dresden, Germany

  • Fiona Stanley Hospital

    Murdoch, Australia

  • Georg-August-Universitaet Goettingen

    Göttingen, Germany

  • Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse

    Hasselt, Belgium

  • Henry Dunant hospital

    Athens, Greece

  • Hopital Prive du Confluent SAS

    Nantes, France

  • Hopital Saint Philibert-Hospital

    Lomme, France

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, Spain

  • Hospital Universitario La Fe

    Valencia, Spain

  • Hospital de Santa Cruz

    Carnaxide, Portugal

  • Institut Jantung Negara

    Kuala Lumpur, Malaysia

  • John Hunter Hospital

    Newcastle, Australia

  • King Fahd Armed Forces Hospital

    Jeddah, Saudi Arabia

  • Liverpool Heart & Chest Hospital

    Liverpool, United Kingdom

  • Mater Private Hospital

    Dublin, Ireland

  • Nemocnice Ceske Budejovice a.s.

    České Budějovice, Czechia

  • Neuron Medical in Brno

    Brno, Czechia

  • Onassis Cardiac Surgery Center

    Athens, Greece

  • Ospedale Isola Tiberina Gemelli Isola

    Roma, Italy

  • Ospedale Rivoli

    Rivoli, Italy

  • Ospedale San Bortolo de Vicenza

    Vicenza, Italy

  • Prince Charles Hospital

    Brisbane, Australia

  • Prince of Wales Hospital

    Hong Kong, Hong Kong

  • Princesse Grace

    Monaco, Monaco

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Royal Papworth Hospital

    Cambridge, United Kingdom

  • Semmelweis University

    Budapest, Hungary

  • St Georg Asklepios

    Hamburg, Germany

  • St. Antonius Ziekenhuis

    Nieuwegein, Netherlands

  • Staedisches Klinikum Karlsruhe

    Karlsruhe, Germany

  • Tays Heart Hospital

    Tampere, Finland

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, Israel

  • Universitaetsklinikum Aachen (UKA)

    Aachen, Germany

  • Universitaetsklinikum Heidelberg

    Heidelberg, Germany

  • University Hospital of Muenster

    Münster, Germany

  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

    Warsaw, Poland

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