A Prospective Clinical Study to Evaluate the Safety and E... | NCT06973031

Studies
A Prospective Clinical Study to Evaluate the Safety and Effectiveness of Pulmonary Vein Isolation Plus Box Isolation of Fibrotic Areas With the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation

NCT06973031

Sponsor

Kardium Inc.

Status

Recruiting

Last Update Posted

Jun 16, 2025Actual

Enrollment

115Estimated

Phase

Not Applicable

Conditions

Paroxysmal Atrial Fibrillation (PAF)
Persistent Atrial Fibrillation

Interventions

Globe Pulsed Field System

Countries

Germany

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

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 10, 2025Actual

Primary Completion Date

Jun 2028Estimated

Completion Date

Jun 2028Estimated

First Submitted Date

May 7, 2025

First Submission Date that Met QC Criteria

May 7, 2025

First Posted Date

May 15, 2025Actual

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 13, 2025

Last Update Posted Date

Jun 16, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study will evaluate the safety and 12-month effectiveness of the Pulmonary Vein Isolation plus Box Isolation of Fibrotic Areas (BIFA) ablation strategy with the Globe Pulsed Field System (Globe PF System) for the treatment of atrial fibrillation.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

115Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Globe Pulsed Field System	Experimental		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	Number of subjects with freedom from documented atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT) 12 months post-procedure.	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.	7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key inclusion criteria:

A diagnosis of recurrent symptomatic paroxysmal or persistent AF
Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III

Key exclusion criteria:

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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

Facility	Status	City	State	ZIP	Country	Contacts
Westpfalz-Klinikum GmbH Kaiserslautern	Recruiting	Kaiserslautern		67655	Germany

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms