Safety and Performance of a GLOBAL Mapping and Ablation Device for the Treatment of Atrial Fibrillation (GLOBAL-AF)

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Global mapping and ablation device

• Registration Number: NCT02168972
• Lead Sponsor: Kardium Inc.

Brief Summary

The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe® Mapping and Ablation System for treating patients with atrial fibrillation.

Detailed Description

Upon successful enrolment, subjects will be scheduled for mapping and radiofrequency (RF) ablation. Cardiac CT imaging, echocardiography and baseline 12-lead ECG will be performed pre-procedure for screening and health assessment. During the procedure the Globe catheter will be delivered via standard femoral vein access and transseptal puncture. Anatomical and electrophysiological mapping of the left atrium (LA) will be followed by RF ablation to achieve pulmonary vein isolation (PVI). Additional lesions will be created as deemed appropriate by the investigator. Intracardiac electrogram mapping will be used to confirm PVI during the procedure. Echocardiography will be performed at discharge to assess cardiac function. Electrocardiograms by 12-lead ECG and 7-day Holter monitoring will be recorded at discharge, and 3, 6 and 12 months after treatment. Follow-up assessments will be performed at discharge, 7 days, and 1, 3, 6 and 12 months after treatment, to track freedom from documented AF and adverse events. Subject-reported AF symptomology and quality of life will also be assessed during follow-up.

Study Timeline

• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-18
• Study First Posted: 2014-06-20
• Study Start: 2014-11
• Primary Completion: 2017-10
• Study Completion: 2019-08
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients indicated for ablation, with a documented history of symptomatic paroxysmal atrial fibrillation
• Between 18 and 80 years of age, inclusive

Exclusion Criteria

• Patients who have contraindications to open heart surgery
• Patients from an Intensive Care Unit
• Patients requiring concurrent right atrial ablation or who have had previous left atrial ablation
• Previous cardiac procedure or known abnormalities that would interfere with device delivery, position, or treatment efficacy
• History of a documented thromboembolic event or bleeding abnormalities
• Contraindication to anticoagulation therapy
• Mental impairment or other conditions, which may not allow patient to understand the nature, significance and scope of the study
• Anatomy that would prevent safe and appropriate introduction or delivery of the Globe device into the patient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Global mapping and ablation device	Global mapping and ablation device	-

Primary Outcome Measures

Name	Time	Method
Rate of subjects presenting pre-defined serious adverse events occurring within 7 days of the procedure	7 days	Rate of subjects presenting with one or more of the following serious adverse events occurring within 7-days of the procedure: * Transient ischemic attack; * Cerebrovascular accident; * Major bleeding; * Cardiac tamponade; * Pulmonary vein stenosis; * Pericarditis; * Myocardial infarction; * Diaphragmatic paralysis; * Atrio-esophageal fistula; * Valvular damage; * Phrenic nerve palsy; * Intra-procedural device complication requiring open chest or heart surgery; * Death

Secondary Outcome Measures

Name	Time	Method
Acute procedural success	Intra-procedurally	Acute device performance in achieving entrance block of the pulmonary veins
Subjects presenting with adverse events	Up to 1 year	* Subjects presenting with primary serious adverse events up to 1 year; * Subjects presenting with adverse events or serious adverse events up to 1 year
Change in Quality of life and AF symptom frequency and severity scores	Up to 1 year	Change of quality of life (SF-36) and AF symptom frequency and severity (Bubien et al 1993) questionnaire scores from baseline to 1 year after ablation
Rate of freedom from documented atrial fibrillation	Between 3 months and 1 year	Rate of freedom from electrocardiographically documented atrial fibrillation between 3 months and 1 year post-ablation

Trial Locations

Locations (2)

Klinik Hirslanden; 🇨🇭 Zürich, Switzerland

Herzzentrum Leipzig GmbH; 🇩🇪 Leipzig, Saxony, Germany