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

NCT02168972 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-10-02

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Global mapping and ablation device

During the procedure the Globe catheter will be delivered via standard femoral vein access and transseptal puncture. Anatomical and electrophysiological mapping of the LA will be followed by pulmonary vein isolation (PVI) by RF ablation. Additional lesions will be created as deemed appropriate by the investigator.

Sponsors & Collaborators

  • Kardium Inc.

    lead INDUSTRY

Principal Investigators

  • Hans Kottkamp, Prof.Dr.med. · Klinik Hirslanden, Zurich

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-10-31
Completion
2019-08-31

Countries

  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02168972 on ClinicalTrials.gov