PulseSelect™ PFA Global Registry

NCT ID: NCT06393920

Last Updated: 2026-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1950 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-23

Study Completion Date

2027-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-approval study. Subjects will be treated with the PulseSelect™ PFA System and followed according to SOC.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-market registry. The purpose of this clinical study is to collect clinical performance and safety data in a broad patient population treated with the PulseSelect™ PFA system. The PulseSelect™ PFA System used in the study is market approved. The ablation procedure will be performed according to routine hospital practice. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medtronic Cardiac Ablation Solutions

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Khaldoun Tarakji, MD

Role: STUDY_DIRECTOR

Medtronic CAS Chief Medical Officer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

McGill University Health Centre (MUHC)

Montreal, Quebec, Canada

Site Status RECRUITING

Fuwai Hospital Chinese Academy of Medical Sciences

Beijing, , China

Site Status RECRUITING

The Second Affiliated Hospital of Harbin Medical University

Harbin, , China

Site Status RECRUITING

Nanjing Drum Tower Hospital

Nanjing, , China

Site Status RECRUITING

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status RECRUITING

Wuhan Asia General Hospital

Wuhan, , China

Site Status RECRUITING

Centre Hospitalier Universitaire de Grenoble - Site Nord

Grenoble, , France

Site Status RECRUITING

Les Hôpitaux de Chartres - Hôpital Louis Pasteur

Le Coudray, , France

Site Status RECRUITING

Hôpital Privé Jacques Cartier

Massy, , France

Site Status RECRUITING

Clinique Pasteur

Toulouse, , France

Site Status RECRUITING

Universitäts Klinikum Frankfurt - Goethe-Universität

Frankfurt, , Germany

Site Status RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Site Status RECRUITING

St. Vincenz Krakenhaus Paderborn

Paderborn, , Germany

Site Status RECRUITING

St. Vincenz-Krankenhaus Paderborn

Paderborn, , Germany

Site Status RECRUITING

Bioclinic Athens

Athens, , Greece

Site Status RECRUITING

IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, Verona, Italy

Site Status RECRUITING

Azienda Ospedaliera di Ancona

Ancona, , Italy

Site Status RECRUITING

St Antonius Ziekenhuis

Nieuwegein, , Netherlands

Site Status RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Hospital Universitario Reina Sofía

Córdoba, , Spain

Site Status RECRUITING

H. Univ. Virgen de la Victoria - Malaga

Málaga, , Spain

Site Status RECRUITING

Complejo Asistencial Universitario de Salamanca

Salamanca, , Spain

Site Status RECRUITING

Basildon and Thurrock University Hospitals

Basildon, , United Kingdom

Site Status NOT_YET_RECRUITING

University Hospitals Coventry & Warwickshire

Coventry, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada China France Germany Greece Italy Netherlands South Korea Spain United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Josman Suri

Role: CONTACT

7635050262

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jason Andrade, MD

Role: primary

(778) 558-5813

Atul Verma, MD

Role: primary

(514) 934-1934

Qi Sun

Role: primary

Shufeng Li

Role: primary

+86 13304505989

Wei Xu

Role: primary

Liqun Wu

Role: primary

+86 13801621536

Xi Su

Role: primary

Pascal Defaye, MD

Role: primary

+33 476765437

Pierre Socié

Role: primary

Jerome Lacotte, MD

Role: primary

+33 160136060

Serge Boveda

Role: primary

+33 562211645

Reza Wakili

Role: primary

+49 6963014803 (-86890)

Patrick Lugenbiel

Role: primary

+49 6221568676

Andreas Götte

Role: primary

+49 5251861651

Andreas Götte, MD

Role: primary

+49 5251861670

Vasilios Vasilios

Role: primary

+30 6948804312

Giulio Molon, MD

Role: primary

+39 0456013111

Paolo Compagnucci

Role: primary

+39 0715965210

Lucas Victor August Boersma, MD

Role: primary

+31 306099111

Il-Young Oh, MD

Role: primary

+82 317877056

Eue-Keun Choi

Role: primary

+82 220720688

Young-Keun On, MD

Role: primary

+82 234103420

Hui Nam Pak, MD

Role: primary

+82 222288459

Jose María Segura Saint-Gerons

Role: primary

+34 609086967

Alberto Barrera Cordero

Role: primary

+34 952603165

Javier J Candil, MD

Role: primary

+34 923291100 Ex 55356

Neil Srinivasan, MD

Role: primary

+44 1268524900

Faizel Osman, MD

Role: primary

+44 2476965668

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PulseSelect™ PFA Registry

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.