Globe Registry: Globe® Pulsed Field System Registry Study... | NCT07651852

Studies
Globe Registry: Globe® Pulsed Field System Registry Study for Treating Patients With Symptomatic Atrial Fibrillation

NCT07651852

Sponsor

Kardium Inc.

Status

Not yet recruiting

Last Update Posted

Jun 16, 2026Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Globe Pulsed Field System

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2026Estimated

Primary Completion Date

Oct 2029Estimated

Completion Date

Oct 2029Estimated

First Submitted Date

Jun 11, 2026

First Submission Date that Met QC Criteria

Jun 11, 2026

First Posted Date

Jun 16, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2026

Last Update Posted Date

Jun 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Globe Pulsed Field System			Device: Globe Pulsed Field System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Globe Pulsed Field System	Device	Ablation and atrial mapping with the Globe Pulsed Field System	Globe Pulsed Field System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effectiveness endpoint	Rate of 12-month treatment success following ablation using the Globe PF System.	12 months
Safety endpoint	Rate of subjects with one or more major adverse events up to 7 days following the index ablation procedure.	7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Patients with a planned ablation procedure using the commercially available Globe PF System

Key Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study population consists of AF participants who are scheduled for treatment using the Globe PF System.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clinical Affairs	Contact	+1 (604) 248 8891		Clinical.Affairs@kardium.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided