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PulseSelect™ PFA Global Registry

Sponsor: Medtronic Cardiac Ablation Solutions

NCT ID: NCT06393920

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 48 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor

In plain English

This registry collects information from people with atrial fibrillation (an irregular heart rhythm) who are having a procedure using the PulseSelect™ PFA System, a commercially available device. The study is run by Medtronic Cardiac Ablation Solutions.

Who can take part

  • You are aged 18 or over, or the minimum age required by local rules
  • You have been diagnosed with atrial fibrillation (an irregular heart rhythm)
  • You are due to have a procedure using the PulseSelect™ PFA System, which is already available commercially
  • You are willing to follow the study requirements and give informed consent (your documented, voluntary agreement to take part), or authorisation as required locally

Who may not be able to

  • You are already taking part in another study that has not been approved for overlap by the global study manager
  • You meet any exclusion criteria set by local law

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team (the registry does not say how many visits, how long it lasts, or what taking part involves).

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
1,950
Started
2024-07-23
Last checked
2026-02

Plain English Summary

What is this study?

  • • Testing a new treatment for atrial fibrillation
  • • Clinical study - 1,950 participants
  • • The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-approval study

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with atrial fibrillation

Where?

  • • Basildon - Basildon and Thurrock University Hospitals
  • • Coventry - University Hospitals Coventry & Warwickshire
  • • London - Saint Georges University Hospitals - NHS Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Atrial Fibrillation

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ by local regulations

What the study is looking for

  • ✓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.

Who cannot take part

  • ✗Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study...
  • ✗Subject with exclusion criteria required by local law.
See the full criteria
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.

Where Is This Study? (3 UK sites)

Basildon and Thurrock University Hospitals

Basildon SS16 5NL, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

University Hospitals Coventry & Warwickshire

Coventry CV2 2DX, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Josie Goodby

research@uhcw.nhs.uk02476 965244

Saint Georges University Hospitals - NHS Trust

London SW17 0QT, United Kingdom

ACTIVE_NOT_RECRUITING

How to Get in Touch

Josman Suri

Sponsor contact

CONTACT

7635050262 josman.suri@medtronic.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-02