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
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
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- 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