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

N/ANot Yet RecruitingNCT07651852

Kardium Inc.500 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

500

Conditions

Atrial Fibrillation

Interventions

Globe Pulsed Field SystemDEVICE

Ablation and atrial mapping with the Globe Pulsed Field System

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Central Contacts

Clinical Affairs

CONTACT

+1 (604) 248 8891 Clinical.Affairs@kardium.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.