PulseSelect™ PFA Global Registry

August 11, 2026 updated by: Medtronic Cardiac Ablation Solutions

PulseSelect PFA Global Registry, a Part of the Medtronic Cardiac Ablation Post-Market Study Platform

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

1950

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Hasselt, Belgium, 3500
        • Active, not recruiting
        • Jessa Ziekenhuis
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Active, not recruiting
        • Vancouver General Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Active, not recruiting
        • McGill University Health Centre (MUHC)
  • China
      • Beijing, China, 100037
        • Recruiting
        • Fuwai Hospital Chinese Academy of Medical Sciences
        • Contact:
      • Fuzhou, China, 350000
        • Recruiting
        • Fujian Provincial Hospital
        • Contact:
        • Principal Investigator:
          • Yazhou Lin
      • Harbin, China, 150001
        • Recruiting
        • The Second Affiliated Hospital of Harbin Medical University
        • Contact:
      • Kunming, China, 650034
        • Recruiting
        • The First Peoples Hospital of Yunnan Province
        • Contact:
      • Nanjing, China, 210008
      • Shanghai, China, 200025
        • Active, not recruiting
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
      • Shenzhen, China, 51000
        • Recruiting
        • Fuwai Shenzhen Hospital Chinese Academy of Medical Sciences
        • Principal Investigator:
          • Jun Liu
        • Contact:
          • Jun Liu
      • Wuhan, China, 430000
      • Xiamen, China, 361001
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Zheng Wuyang
        • Principal Investigator:
          • Zheng Wuyang
      • Zhengzhou, China, 451400
        • Recruiting
        • Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:
      • Ürümqi, China, 830054
        • Active, not recruiting
        • The First Affiliated Hospital of Xinjiang Medical University
  • Croatia
      • Zagreb, Croatia, 10000
        • Recruiting
        • Klinički Bolnički Centar Zagreb (KBC)
        • Contact:
        • Principal Investigator:
          • Vedran Velagic
      • Zagreb, Croatia, 10000
        • Active, not recruiting
        • Klinicka bolnica Dubrava
  • France
      • Grenoble, France, 38700
        • Active, not recruiting
        • Centre Hospitalier Universitaire de Grenoble - Site Nord
      • Le Coudray, France, 28630
        • Active, not recruiting
        • Les Hôpitaux de Chartres - Hôpital Louis Pasteur
      • Massy, France, 91300
        • Active, not recruiting
        • Hôpital Privé Jacques Cartier
      • Paris, France, 75015
        • Active, not recruiting
        • Hôpital Européen Georges Pompidou
      • Toulouse, France, 31076
        • Active, not recruiting
        • Clinique Pasteur
  • Germany
      • Frankfurt, Germany, 60590
        • Active, not recruiting
        • Universitäts Klinikum Frankfurt - Goethe-Universität
      • Heidelberg, Germany, 69120
        • Active, not recruiting
        • Universitätsklinikum Heidelberg
      • Ludwigshafen am Rhein, Germany, 67063
        • Active, not recruiting
        • Klinikum der Stadt Ludwigshafen
      • Paderborn, Germany, 33098
        • Recruiting
        • St. Vincenz-Krankenhaus Paderborn
        • Contact:
      • Paderborn, Germany, 33098
        • Active, not recruiting
        • St. Vincenz Krakenhaus Paderborn
  • Greece
      • Athens, Greece, 11524
        • Active, not recruiting
        • Bioclinic Athens
  • Italy
      • Ancona, Italy, 60030
        • Active, not recruiting
        • Azienda Ospedaliera di Ancona
    • Verona
      • Negrar, Verona, Italy, 37024
        • Active, not recruiting
        • IRCCS Ospedale Sacro Cuore Don Calabria
  • Netherlands
      • Nieuwegein, Netherlands, 3435 CM
        • Active, not recruiting
        • St Antonius Ziekenhuis
  • New Zealand
      • Auckland, New Zealand, 1023
  • Romania
      • Brasov, Romania, 500826
        • Active, not recruiting
        • Spitalul Clinic Judetean de Urgenta Brasov
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Active, not recruiting
        • University Medical Centre Ljubljana
  • South Korea
      • Seoul, South Korea, 06351
        • Active, not recruiting
        • Samsung Medical Center
      • Seoul, South Korea, 120-752
        • Active, not recruiting
        • Severance Hospital
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 463-707
        • Active, not recruiting
        • Seoul National University Bundang Hospital
    • Seoul
      • Seoul, Seoul, South Korea, 03080
        • Active, not recruiting
        • Seoul National University Hospital
  • Spain
      • Córdoba, Spain, 14004
        • Active, not recruiting
        • Hospital Universitario Reina Sofia
      • Málaga, Spain, 29010
        • Active, not recruiting
        • H. Univ. Virgen de la Victoria - Malaga
      • Salamanca, Spain, 37007
        • Active, not recruiting
        • Complejo Asistencial Universitario de Salamanca
  • United Kingdom
      • Basildon, United Kingdom, SS16 5NL
        • Not yet recruiting
        • Basildon and Thurrock University Hospitals
        • Contact:
      • Coventry, United Kingdom, CV2 2DX
        • Active, not recruiting
        • University Hospitals Coventry & Warwickshire
      • London, United Kingdom, SW17 0QT
        • Active, not recruiting
        • Saint Georges University Hospitals - NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy-Freedom from Atrial Fibrillation
Time Frame: ≥ 91 days after the index ablation procedure
Estimate the freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA system.
≥ 91 days after the index ablation procedure
Safety- Freedom from Device/Procedure Related Adverse Events
Time Frame: Within 6 months post-ablation
Estimate serious device and serious procedure-related adverse events for the PulseSelect™ PFA system
Within 6 months post-ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Ablation Solutions

Investigators

  • Study Director: Khaldoun Tarakji, MD, Medtronic CAS Chief Medical Officer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

April 28, 2024

First Submitted That Met QC Criteria

April 28, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2026

Last Update Submitted That Met QC Criteria

August 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PulseSelect™ PFA Registry

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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