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New heart device registry tracks Real-World results for 1,950 AFib patients

NCT ID NCT06393920

Knowledge-focused Sponsor: Medtronic Cardiac Ablation Solutions Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 14, 2026 · Updated 4 times

Summary

This registry is following 1,950 people with atrial fibrillation who are treated with the PulseSelect PFA system, a device that uses electrical pulses to correct irregular heartbeats. Researchers are tracking how well the procedure prevents AFib from coming back and how often serious side effects occur. The goal is to see how the device works in everyday medical practice.

What this could mean

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

Active substance
PulseSelect PFA system (a device that uses pulsed field ablation to treat atrial fibrillation)
What this could lead to
If successful, this registry will confirm that the PulseSelect PFA system is safe and effective for routine use in treating atrial fibrillation.
What could go wrong
This is an observational registry, not a controlled trial, so results may be influenced by patient selection or other factors. It does not test a new treatment, only monitors existing practice.

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

About 1,950 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jul 2028

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 18 years or older with a planned procedure using commercially available PulseSelect™ PFA System

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: * Subject is ≥ 18 years of age or minimum age as required by local regulations. * Subject has been diagnosed with atrial fibrillation (AF) * Planned procedure using commercially available PulseSelect™ PFA System. * Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements. Exclusion Criteria: * Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager. * Subject with exclusion criteria required by local law.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Auckland Hospital

    RECRUITING

    Auckland, 1023, New Zealand

  • Azienda Ospedaliera di Ancona

    ACTIVE_NOT_RECRUITING

    Ancona, 60030, Italy

  • Basildon and Thurrock University Hospitals

    NOT_YET_RECRUITING

    Basildon, SS16 5NL, United Kingdom

  • Bioclinic Athens

    ACTIVE_NOT_RECRUITING

    Athens, 11524, Greece

  • Centre Hospitalier Universitaire de Grenoble - Site Nord

    ACTIVE_NOT_RECRUITING

    Grenoble, 38700, France

  • Clinique Pasteur

    ACTIVE_NOT_RECRUITING

    Toulouse, 31076, France

  • Complejo Asistencial Universitario de Salamanca

    ACTIVE_NOT_RECRUITING

    Salamanca, 37007, Spain

  • Fujian Provincial Hospital

    RECRUITING

    Fuzhou, 350000, China

  • Fuwai Hospital Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, 100037, China

  • Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College

    RECRUITING

    Zhengzhou, 451400, China

  • Fuwai Shenzhen Hospital Chinese Academy of Medical Sciences

    RECRUITING

    Shenzhen, 51000, China

  • H. Univ. Virgen de la Victoria - Malaga

    ACTIVE_NOT_RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitario Reina Sofía

    ACTIVE_NOT_RECRUITING

    Córdoba, 14004, Spain

  • Hôpital Européen Georges Pompidou

    ACTIVE_NOT_RECRUITING

    Paris, 75015, France

  • Hôpital Privé Jacques Cartier

    ACTIVE_NOT_RECRUITING

    Massy, 91300, France

  • IRCCS Ospedale Sacro Cuore Don Calabria

    ACTIVE_NOT_RECRUITING

    Negrar, Verona, 37024, Italy

  • Jessa Ziekenhuis

    ACTIVE_NOT_RECRUITING

    Hasselt, 3500, Belgium

  • Klinikum der Stadt Ludwigshafen

    ACTIVE_NOT_RECRUITING

    Ludwigshafen am Rhein, 67063, Germany

  • Klinička Bolnica Dubrava

    ACTIVE_NOT_RECRUITING

    Zagreb, 10000, Croatia

  • Klinički Bolnički Centar Zagreb (KBC)

    RECRUITING

    Zagreb, 10000, Croatia

  • Les Hôpitaux de Chartres - Hôpital Louis Pasteur

    ACTIVE_NOT_RECRUITING

    Le Coudray, 28630, France

  • McGill University Health Centre (MUHC)

    ACTIVE_NOT_RECRUITING

    Montreal, Quebec, H3G 1A4, Canada

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, 210008, China

  • Ruijin Hospital Shanghai Jiao Tong University School of Medicine

    ACTIVE_NOT_RECRUITING

    Shanghai, 200025, China

  • Saint Georges University Hospitals - NHS Trust

    ACTIVE_NOT_RECRUITING

    London, SW17 0QT, United Kingdom

  • Samsung Medical Center

    ACTIVE_NOT_RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    ACTIVE_NOT_RECRUITING

    Seongnam-si, Gyeonggi-do, 463-707, South Korea

  • Seoul National University Hospital

    ACTIVE_NOT_RECRUITING

    Seoul, Seoul, 03080, South Korea

  • Severance Hospital

    ACTIVE_NOT_RECRUITING

    Seoul, 120-752, South Korea

  • Spitalul Clinic Județean de Urgență Brașov

    ACTIVE_NOT_RECRUITING

    Brasov, 500826, Romania

  • St Antonius Ziekenhuis

    ACTIVE_NOT_RECRUITING

    Nieuwegein, 3435 CM, Netherlands

  • St. Vincenz Krakenhaus Paderborn

    ACTIVE_NOT_RECRUITING

    Paderborn, 33098, Germany

  • St. Vincenz-Krankenhaus Paderborn

    RECRUITING

    Paderborn, 33098, Germany

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, 361001, China

  • The First Affiliated Hospital of Xinjiang Medical University

    ACTIVE_NOT_RECRUITING

    Ürümqi, 830054, China

  • The First Peoples Hospital of Yunnan Province

    RECRUITING

    Kunming, 650034, China

  • The Second Affiliated Hospital of Harbin Medical University

    RECRUITING

    Harbin, 150001, China

  • University Hospitals Coventry & Warwickshire

    ACTIVE_NOT_RECRUITING

    Coventry, CV2 2DX, United Kingdom

  • University Medical Centre Ljubljana

    ACTIVE_NOT_RECRUITING

    Ljubljana, 1000, Slovenia

  • Universitäts Klinikum Frankfurt - Goethe-Universität

    ACTIVE_NOT_RECRUITING

    Frankfurt, 60590, Germany

  • Universitätsklinikum Heidelberg

    ACTIVE_NOT_RECRUITING

    Heidelberg, 69120, Germany

  • Vancouver General Hospital

    ACTIVE_NOT_RECRUITING

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Wuhan Asia General Hospital

    RECRUITING

    Wuhan, 430000, China

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