Paroxysmal Atrial FibrillationPULSARNCT05462145
Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
A study testing Globe Pulsed Field System in people with Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Kardium Inc. at 17 sites in 4 countries.
Trial summary
This study will evaluate the safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal or persistent atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- What is being tested?
- Globe Pulsed Field System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 549 participants
- Where
- 17 sitesin 4 countries
- Study dates
- 9 Mar 2023to Mar 2029
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of recurrent symptomatic paroxysmal or persistent AF
- Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III or AAD naïve subjects
Who cannot join
- Long-standing persistent AF (sustained >12 months)
- Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
- History of thromboembolic events within the past six months
- Myocardial infarction (MI)/percutaneous coronary intervention (PCI) within the last three months
- Any cardiac surgery within the previous six months
- Prior left atrial ablation or surgical procedure
Show all 11Show fewer
- Presence of an implanted cardiac device
- Body mass index (BMI) >40 kg/m^2
- Left ventricular ejection fraction (LVEF) <35%
- Anterior-posterior left atrial (LA) diameter >55mm
- Right atrial minor-axis (transverse) diameter <32mm for adjunctive cavotricuspid isthmus (CTI) ablation only
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
United States11 sites
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
Johns Hopkins
Baltimore, Maryland, 21287
Grandview Medical Center
Birmingham, Alabama, 35243
Cleveland Clinic
Cleveland, Ohio, 44195
St. Vincent's Medical Center
Jacksonville, Florida, 32204
St. Bernards Medical Center
Jonesboro, Arkansas, 72401
Mercy Hospital
Miami, Florida, 33133
Mt. Sinai Hospital, Guggenheim Pavilion
New York, New York, 10029
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Beaumont Hospital
Royal Oak, Michigan, 48073
Sutter Health - California Pacific Medical Center
San Francisco, California, 94109
Germany3 sites
Heart and Diabetes Center NRW
Bad Oeynhausen
Charité Campus Virchow Clinic
Berlin
Westpfalz-Klinikum GmbH Kaiserslautern
Kaiserslautern, 67655
Canada2 sites
McGill University Health Centre
Montreal, Quebec, H4A 3J1
St.Paul's Hospital
Vancouver, British Columbia, V6E 1M7
About this study
Official title: A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
This study will evaluate the safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal or persistent atrial fibrillation (AF).
- Being tested
- Globe Pulsed Field System
- Keywords
- Pulsed Field Ablation, Irreversible Electroporation
- 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 Pulsed Field SystemDevice
Ablation and atrial mapping with the Globe Pulsed Field System
| Study group | Role | What they receive |
|---|---|---|
| Globe Pulsed Field System | Experimental | Not described Receives: Device: Globe Pulsed Field System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness endpoint
Number of subjects with freedom from documented atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT) 12 months post-procedure.
Measured: 12 months
Safety endpoint
Rate of subjects presenting with one or more of the specified primary safety events within 7 days of the index ablation procedure.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start9 Mar 2023
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 549 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kardium Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462145
- Sponsor's protocol ID
- DOC-189367
- Acronym
- PULSAR
- Status last verified
- Oct 2026
- First submitted
- 13 Jul 2022
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Reddy VY, Kottkamp H, Calkins H, Nair DG, Sommer P, Hussein AA, Schumacher B, Dukkipati S, Neuzil P, Oza S, Woods C, Deyell MW, Osorio J, Verma A; PULSAR Investigators. Pulsed-Field Ablation to Enhance the Durability of Pulmonary Vein Isolation and Treat Paroxysmal Atrial Fibrillation. J Am Coll Cardiol. 2026 Apr 14;87(14):1747-1761. doi: 10.1016/j.jacc.2025.10.084. Epub 2026 Jan 21.
PubMed 41563170
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05462145
- Acronym / sponsor ID
- PULSAR / DOC-189367
- Keywords
- Pulsed Field Ablation, Irreversible Electroporation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 549 participants (estimated)
- Lead sponsor
- Kardium Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 18 Jul 2022 (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.
This study will evaluate the safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal or persistent atrial fibrillation (AF).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Globe Pulsed Field System | Experimental | Device: Globe Pulsed Field System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A diagnosis of recurrent symptomatic paroxysmal or persistent AF
- Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III or AAD naïve subjects
Key exclusion criteria (11 listed)
- Long-standing persistent AF (sustained >12 months)
- Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
- History of thromboembolic events within the past six months
- Myocardial infarction (MI)/percutaneous coronary intervention (PCI) within the last three months
- Any cardiac surgery within the previous six months
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 Pulsed Field SystemAblation and atrial mapping with the Globe Pulsed Field System | Device | Globe Pulsed Field System |
Primary outcome
Effectiveness endpoint
Time frame: 12 months
Number of subjects with freedom from documented atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT) 12 months post-procedure.
Safety endpoint
Time frame: 7 days
Rate of subjects presenting with one or more of the specified primary safety events within 7 days of the index ablation procedure.
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 6 Oct 2026.
- Background: PubMed 41563170Reddy VY, Kottkamp H, Calkins H, Nair DG, Sommer P, Hussein AA, Schumacher B, Dukkipati S, Neuzil P, Oza S, Woods C, Deyell MW, Osorio J, Verma A; PULSAR Investigators. Pulsed-Field Ablation to Enhance the Durability of Pulmonary Vein Isolation and Treat Paroxysmal Atrial Fibrillation. J Am Coll Cardiol. 2026 Apr 14;87(14):1747-1761. doi: 10.1016/j.jacc.2025.10.084. Epub 2026 Jan 21.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Globe Pulsed Field System in people with Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Kardium Inc. at 17 sites in 4 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 2 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 6 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 17 sites in United States, Germany, Canada, 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness endpoint (time frame: 12 months). 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?
On the ClinicalTrials.gov record for NCT05462145, which also lists 1 linked publication.
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 6 Oct 2026.