Atrial FibrillationNCT06393920
PulseSelect™ PFA Global Registry
An observational study of Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 43 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 1,950 participants
- Where
- 43 sitesin 16 countries
- Study dates
- 23 Jul 2024to 31 Jul 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects 18 years or older with a planned procedure using commercially available PulseSelect™ PFA System
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
43 sites in 16 countries. Contact the study team or a site near you to ask about taking part.
43 sites in 16 countries
China11 sites
- Active, not recruiting
Fuwai Hospital Chinese Academy of Medical Sciences
Beijing, 100037
- Active, not recruiting
Fujian Provincial Hospital
Fuzhou, 350000
- Active, not recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, 150001
- Active, not recruiting
The First Peoples Hospital of Yunnan Province
Kunming, 650034
- Active, not recruiting
Nanjing Drum Tower Hospital
Nanjing, 210008
- Active, not recruiting
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
- Active, not recruiting
Fuwai Shenzhen Hospital Chinese Academy of Medical Sciences
Shenzhen, 51000
- Active, not recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, 830054
- Active, not recruiting
Wuhan Asia General Hospital
Wuhan, 430000
- Active, not recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, 361001
- Active, not recruiting
Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
Zhengzhou, 451400
France5 sites
- Active, not recruiting
Centre Hospitalier Universitaire de Grenoble - Site Nord
Grenoble, 38700
- Active, not recruiting
Les Hôpitaux de Chartres - Hôpital Louis Pasteur
Le Coudray, 28630
- Active, not recruiting
Hôpital Privé Jacques Cartier
Massy, 91300
- Active, not recruiting
Hôpital Européen Georges Pompidou
Paris, 75015
- Active, not recruiting
Clinique Pasteur
Toulouse, 31076
Germany5 sites
- Active, not recruiting
Universitäts Klinikum Frankfurt - Goethe-Universität
Frankfurt, 60590
- Active, not recruiting
Universitätsklinikum Heidelberg
Heidelberg, 69120
- Active, not recruiting
Klinikum der Stadt Ludwigshafen
Ludwigshafen am Rhein, 67063
- Active, not recruiting
St. Vincenz Krakenhaus Paderborn
Paderborn, 33098
- Active, not recruiting
St. Vincenz-Krankenhaus Paderborn
Paderborn, 33098
South Korea4 sites
- Active, not recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
- Active, not recruiting
Seoul National University Hospital
Seoul, Seoul, 03080
- Active, not recruiting
Samsung Medical Center
Seoul, 06351
- Active, not recruiting
Severance Hospital
Seoul, 120-752
Spain3 sites
- Active, not recruiting
Hospital Universitario Reina Sofía
Córdoba, 14004
- Active, not recruiting
H. Univ. Virgen de la Victoria - Malaga
Málaga, 29010
- Active, not recruiting
Complejo Asistencial Universitario de Salamanca
Salamanca, 37007
Canada2 sites
- Active, not recruiting
McGill University Health Centre (MUHC)
Montreal, Quebec, H3G 1A4
- Active, not recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Croatia2 sites
- Active, not recruiting
Klinička Bolnica Dubrava
Zagreb, 10000
- Active, not recruiting
Klinički Bolnički Centar Zagreb (KBC)
Zagreb, 10000
Italy2 sites
- Active, not recruiting
Azienda Ospedaliera di Ancona
Ancona, 60030
- Active, not recruiting
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, Verona, 37024
United Kingdom2 sites
- Active, not recruiting
University Hospitals Coventry & Warwickshire
Coventry, CV2 2DX
- Active, not recruiting
Saint Georges University Hospitals - NHS Trust
London, SW17 0QT
Australia1 site, 1 recruiting
- Recruiting
Epworth Richmond
Richmond, Victoria, 3121
Andrei Catanchin, MBBS, +61 892248069, andrei.catanchin@gmail.com
Andrei Catanchin, MBBS
Netherlands1 site
- Active, not recruiting
St Antonius Ziekenhuis
Nieuwegein, 3435 CM
New Zealand1 site, 1 recruiting
- Recruiting
Auckland Hospital
Auckland, 1023
Andrew Martin, andrewma@adhb.govt.nz
Romania1 site
- Active, not recruiting
Spitalul Clinic Județean de Urgență Brașov
Brasov, 500826
Slovenia1 site
- Active, not recruiting
University Medical Centre Ljubljana
Ljubljana, 1000
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy-Freedom from Atrial Fibrillation
Estimate the freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA system.
Measured: ≥ 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
Measured: Within 6 months post-ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start23 Jul 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,950 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Ablation Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Khaldoun Tarakji, MD, Study director, Medtronic CAS Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393920
- Sponsor's protocol ID
- PulseSelect™ PFA Registry
- Status last verified
- Feb 2026
- First submitted
- 28 Apr 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PulseSelect PFA Global Registry, a Part of the Medtronic Cardiac Ablation Post-Market Study Platform
- ClinicalTrials.gov ID
- NCT06393920
- Acronym / sponsor ID
- PulseSelect™ PFA Registry
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,950 participants (estimated)
- Lead sponsor
- Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects 18 years or older with a planned procedure using commercially available PulseSelect™ PFA System
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Khaldoun Tarakji, MD study director
Medtronic CAS Chief Medical Officer
43 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 43 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in China, France, Germany, South Korea, Spain and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josman Suri (7635050262, josman.suri@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy-Freedom from Atrial Fibrillation (time frame: ≥ 91 days after the index ablation procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.