A Retrospective Multicenter Post-Market Clinical Follow-up Registry Comparing Safety and Effectiveness Outcomes of Epicardial Cardiac Ablation Using Remote Navigation to Manual Techniques
Status: Completed
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
Retrospective registry will compare subjects who've undergone a mapping and/or ablation procedure for either ischemic ventricular tachycardia or premature ventricular contraction using an epicardial approach with either manual or remote magnetic navigation. Subjects will be compared with regards to safety, efficacy and mortality.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:
• 18 years of age or older
• Have undergone an epicardial RF mapping and/or ablation for a ventricular tachycardia (VT) as standard of care treatment using either the Niobe MNS or a manual approach
• Index procedure was conducted between July 1, 2013-present date.
Locations
Other Locations
Netherlands
OLVG Hospital
Amsterdam
Erasmus Medical Center
Rotterdam
Time Frame
Start Date: 2020-10-02
Completion Date: 2023-03-30
Participants
Target number of participants: 40
Treatments
Manual
Subjects who underwent epicardial mapping and/or ablation using a manual technique will comprise this group.
Remote Magnetic Navigation
Subjects who underwent epicardial mapping and/or ablation using a remote magnetic technique (using Stereotaxis Niobe system) will comprise this group.
Related Therapeutic Areas
Sponsors
Leads: Stereotaxis