Atrial FibrillationNCT07651852
Globe Registry: Globe® Pulsed Field System Registry Study for Treating Patients With Symptomatic Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Kardium Inc. at 2 sites in United States.
Trial summary
This post-market registry is designed to collect real world data on the use of the Globe PF System for the treatment of atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Globe Pulsed Field System
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Oct 2026to Oct 2029
- 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: The study population consists of AF participants who are scheduled for treatment using the Globe PF System.
Who may be able to join
- Patients with a planned ablation procedure using the commercially available Globe PF System
Who cannot join
- Patients whose life expectancy is 1 year or less
- Contraindication to left atrial catheter ablation or PF ablation
- Current enrollment in any investigational study of a medical device, biologic, or drug not pre-approved by Kardium
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Overlake Hospital
Bellevue, Washington, 98004
Maheer Gandhavadi, MD
- Recruiting
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
Devi Nair, MD
About this study
This post-market registry is designed to collect real world data on the use of the Globe PF System for the treatment of atrial fibrillation (AF).
- Conditions
- Atrial Fibrillation
- Being tested
- Globe Pulsed Field System
- 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 | 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
Rate of 12-month treatment success following ablation using the Globe PF System.
Measured: 12 months
Safety endpoint
Rate of subjects with one or more major adverse events up to 7 days following 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 posted16 Jun 2026
- Study start9 Oct 2026
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (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
- 500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Kardium Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651852
- Sponsor's protocol ID
- DOC-321283
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Globe Registry: Globe® Pulsed Field System Registry Study for Treating Patients With Symptomatic Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07651852
- Acronym / sponsor ID
- DOC-321283
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Kardium Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2026 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 16 Jun 2026 (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 post-market registry is designed to collect real world data on the use of the Globe PF System for the treatment of atrial fibrillation (AF).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Globe Pulsed Field System | – | Device: Globe Pulsed Field System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of AF participants who are scheduled for treatment using the Globe PF System.
Key inclusion criteria (1 listed)
- Patients with a planned ablation procedure using the commercially available Globe PF System
Key exclusion criteria (3 listed)
- Patients whose life expectancy is 1 year or less
- Contraindication to left atrial catheter ablation or PF ablation
- Current enrollment in any investigational study of a medical device, biologic, or drug not pre-approved by Kardium
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
Rate of 12-month treatment success following ablation using the Globe PF System.
Safety endpoint
Time frame: 7 days
Rate of subjects with one or more major adverse events up to 7 days following 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 26 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Kardium Inc. at 2 sites in United States.
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 1 inclusion and 3 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 26 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 2 sites in United States. 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?
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?
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 26 Oct 2026.