October 15, 2019 — Kardium Inc. announced that the Globe mapping and ablation system has successfully demonstrated safety and efficacy in the GLOBAL-AF study. The results of the study were published in the Journal of Cardiovascular Electrophysiology. The study demonstrated a 76 percent percent freedom from atrial fibrillation at 12 months after a single treatment with the Globe system.
“I am very excited about the results from this first clinical experience with the Globe system” said Prof. Hans Kottkamp, head of electrophysiology, Sana Hospitals, Düsseldorf, Germany, the principal investigator. “The Globe system has demonstrated the ability to provide rapid and effective pulmonary vein isolation. In addition, the ability to perform high-resolution mapping and ablation of the atrium will deliver a unique and comprehensive treatment for patients that has the potential to further improve outcomes and advance new strategies for the treatment of AF.”
The Globe system is a mapping and ablation solution that consists of a catheter with 122 electrodes and advanced software, that together enable rapid pulmonary vein isolation, high-resolution mapping and the ability to ablate anywhere in the atrium, all with a single catheter.
Atrial fibrillation is the most common heart rhythm disorder and affects about 33 million people worldwide. It can increase the risk of stroke by up to five times.
The GLOBAL-AF study is a prospective multicenter study that evaluated the safety and effectiveness of the system in 60 patients at two centers in Europe. Patients were assessed for atrial fibrillation with seven-day continuous Holter monitoring at discharge and then 3, 6 and 12 months after the treatment. Patients in the efficacy cohort had 100 percent pulmonary vein isolation and 76 percent freedom from atrial fibrillation at 12 months, off antiarrhythmic drugs, after a single procedure.
For more information: www.kardium.com
1. Kottkamp H., Hindricks G., Ponisch C., et al. Global multielectrode contact‐mapping plus ablation with a single catheter in patients with atrial fibrillation: Global AF study. Journal of Cardiovascular Electrophysiology, published online Sept. 11, 2019. https://doi.org/10.1111/jce.14172