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

ConditionAtrial Fibrillation

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorKardium Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Globe Pulsed Field System
Device
Ablation and atrial mapping with the Globe Pulsed Field System

Treatment groups

500 Participants

are divided into 1 treatment group

Group A: Globe Pulsed Field System1 intervention

Trial outcomes

Primary outcomes

Effectiveness endpoint

Rate of 12-month treatment success following ablation using the Globe PF System.

Time frame

12 months

Safety endpoint

Rate of subjects with one or more major adverse events up to 7 days following the index ablation procedure.

Time frame

7 days

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kardium Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: