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

Kardium

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Device: Global mapping and ablation device

Study type

Interventional

Funder types

Industry

Identifiers

NCT02168972

DOC-19996

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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