NCT06393920

Brief Summary

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.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,950

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Jul 2024

Typical duration for all trials

Geographic Reach
10 countries

28 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Jul 2024Jul 2027

First Submitted

Initial submission to the registry

April 28, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

July 23, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

April 28, 2024

Last Update Submit

February 4, 2026

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • Efficacy-Freedom from Atrial Fibrillation

    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

    Estimate serious device and serious procedure-related adverse events for the PulseSelect™ PFA system

    Within 6 months post-ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

McGill University Health Centre (MUHC)

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

Fuwai Hospital Chinese Academy of Medical Sciences

Beijing, 100037, China

RECRUITING

The Second Affiliated Hospital of Harbin Medical University

Harbin, 150001, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, 210008, China

RECRUITING

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, 200025, China

RECRUITING

Wuhan Asia General Hospital

Wuhan, 430000, China

RECRUITING

Centre Hospitalier Universitaire de Grenoble - Site Nord

Grenoble, 38700, France

RECRUITING

Les Hôpitaux de Chartres - Hôpital Louis Pasteur

Le Coudray, 28630, France

RECRUITING

Hôpital Privé Jacques Cartier

Massy, 91300, France

RECRUITING

Clinique Pasteur

Toulouse, 31076, France

RECRUITING

Universitäts Klinikum Frankfurt - Goethe-Universität

Frankfurt, 60590, Germany

RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

RECRUITING

St. Vincenz Krakenhaus Paderborn

Paderborn, 33098, Germany

RECRUITING

St. Vincenz-Krankenhaus Paderborn

Paderborn, 33098, Germany

RECRUITING

Bioclinic Athens

Athens, 11524, Greece

RECRUITING

IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, Verona, 37024, Italy

RECRUITING

Azienda Ospedaliera di Ancona

Ancona, 60030, Italy

RECRUITING

St Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

RECRUITING

Seoul National University Bundang Hospital

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

RECRUITING

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Severance Hospital

Seoul, 120-752, South Korea

RECRUITING

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

RECRUITING

H. Univ. Virgen de la Victoria - Malaga

Málaga, 29010, Spain

RECRUITING

Complejo Asistencial Universitario de Salamanca

Salamanca, 37007, Spain

RECRUITING

Basildon and Thurrock University Hospitals

Basildon, SS16 5NL, United Kingdom

NOT YET RECRUITING

University Hospitals Coventry & Warwickshire

Coventry, CV2 2DX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Khaldoun Tarakji, MD

    Medtronic CAS Chief Medical Officer

    STUDY DIRECTOR

Central Study Contacts

Josman Suri

CONTACT

7635050262josman.suri@medtronic.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2024

First Posted

May 1, 2024

Study Start

July 23, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

DE(4)ES(3)NL(1)CA(2)FR(4)GB(2)GR(1)IT(2)KR(4)CN(5)