NCT07651852

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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
39mo left

Started Jul 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Oct 2029

First Submitted

Initial submission to the registry

June 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

3.3 years

First QC Date

June 11, 2026

Last Update Submit

June 11, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Globe Pulsed Field System

Device: Globe Pulsed Field System

Interventions

Ablation and atrial mapping with the Globe Pulsed Field System

Globe Pulsed Field System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2026

First Posted

June 16, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2029

Last Updated

June 16, 2026

Record last verified: 2026-06