Atrial FibrillationPULSE-EUNCT05164107
Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
A study testing Globe Mapping and Pulsed Field Ablation System (Globe PF System) in people with Atrial Fibrillation, run by Kardium Inc. at 1 site in Czechia.
Trial summary
The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Globe Mapping and Pulsed Field Ablation System (Globe PF System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteCzechia
- Study dates
- 8 Dec 2021to May 2027
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects planned for an AF catheter ablation procedure, with a documented history of AF.
- Diagnosis must be confirmed within 12 months before enrollment.
- (Repeat ablations) Patient had 1 previous PVI procedure with cryoablation, radiofrequency ablation or pulsed field ablation
- Subjects between 18 and 75 years of age, inclusive
Who cannot join
- Patients who have contraindications to open heart surgery
- Patients from an Intensive Care Unit
- Patients with active systemic infection (sepsis)
- Patients who have had previous ablation in the left or right atrium
- Patients who are post-heart transplant or who are awaiting cardiac transplantation or other cardiac surgery
- Patients with cardiac implants that may interfere with device delivery or positioning (e.g. atrial septal defect closure device, left atrial appendage occluder)
Show all 16Show fewer
- Patients with mitral valve prolapse or other heart valve abnormalities excepting mild to moderate mitral regurgitation
- Patients with New York Heart Association Class III or IV heart failure
- History of a documented thromboembolic event, including stroke or transient ischemic attack (TIA)
- Bleeding disorder history
- Patients with a known sensitivity to anesthesia or neuromuscular block agent
- Currently undergoing long-term treatment with steroids, not including intermittent use of inhaled steroids for respiratory disease
- Myocardial infarction within the last three months
- Atrioventricular (AV) block II° or III°
- Left ventricular ejection fraction (LVEF) of less than 35%
- Unstable angina
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Motol and Homolka University Hospital
Prague, 150 00
About this study
Official title: PULSE-EU - A Prospective, Non-Randomized Clinical Pilot Study to Assess Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).
- Conditions
- Atrial Fibrillation
- Being tested
- Globe Mapping and Pulsed Field Ablation System (Globe PF System)
- Keywords
- Globe Mapping and Ablation System, Atrial Fibrillation, Pulsed Field Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Globe Mapping and Pulsed Field Ablation System (Globe PF System)Device
During the procedure, the Globe Catheter will be delivered via standard femoral vein access and transseptal puncture. Anatomical and electrophysiological mapping of the left atrium (LA) will be followed by pulsed field ablation (PFA) to achieve pulmonary vein isolation (PVI). Additional PFA or radiofrequency (RF) ablation lesions may be created as deemed appropriate by the Investigator. Intracardiac electrogram mapping with the Globe PF System will be used to confirm PVI.
| Study group | Role | What they receive |
|---|---|---|
| Globe Mapping and Pulsed Field Ablation System | Experimental | Not described Receives: Device: Globe Mapping and Pulsed Field Ablation System (Globe PF System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of subjects presenting with primary safety events which are device- or procedure-related
Measured: up to 3-month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start8 Dec 2021
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kardium Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Motol and Homolka University Hospital, Principal investigator, V Úvalu 84/1, 150 00 Prague 5, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164107
- Sponsor's protocol ID
- DOC-140832
- Acronym
- PULSE-EU
- Status last verified
- Jan 2026
- First submitted
- 6 Dec 2021
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PULSE-EU - A Prospective, Non-Randomized Clinical Pilot Study to Assess Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05164107
- Acronym / sponsor ID
- PULSE-EU / DOC-140832
- Conditions
- Atrial Fibrillation
- Keywords
- Globe Mapping and Ablation System, Atrial Fibrillation, Pulsed Field Ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Kardium Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 20 Dec 2021 (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 purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Globe Mapping and Pulsed Field Ablation System | Experimental | Device: Globe Mapping and Pulsed Field Ablation System (Globe PF System) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects planned for an AF catheter ablation procedure, with a documented history of AF.
- Subjects between 18 and 75 years of age, inclusive
Key exclusion criteria (16 listed)
- Patients who have contraindications to open heart surgery
- Patients from an Intensive Care Unit
- Patients with active systemic infection (sepsis)
- Patients who have had previous ablation in the left or right atrium
- Patients who are post-heart transplant or who are awaiting cardiac transplantation or other cardiac surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Globe Mapping and Pulsed Field Ablation System (Globe PF System)During the procedure, the Globe Catheter will be delivered via standard femoral vein access and transseptal puncture. Anatomical and electrophysiological mapping of the left atrium (LA) will be followed by pulsed field ablation (PFA) to achieve pulmonary vein isolation (PVI). Additional PFA or radiofrequency (RF) ablation lesions may be created as deemed appropriate by the Investigator. Intracardiac electrogram mapping with the Globe PF System will be used to confirm PVI. | Device | Globe Mapping and Pulsed Field Ablation System |
Primary outcome
Rate of subjects presenting with primary safety events which are device- or procedure-related
Time frame: up to 3-month visit
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 30 Jan 2026.
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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Atrial Fibrillation (AF)
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.
Motol and Homolka University Hospital principal investigator
V Úvalu 84/1, 150 00 Prague 5, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Globe Mapping and Pulsed Field Ablation System (Globe PF System) in people with Atrial Fibrillation, run by Kardium Inc. at 1 site in Czechia.
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 16 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 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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 Clinical Affairs (+1 (604) 248 8891, Clinical.Affairs@kardium.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of subjects presenting with primary safety events which are device- or procedure-related (time frame: up to 3-month visit). 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 30 Jan 2026.