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RMN Versus Manual Epicardial Retrospective PMCF — EPINAV  

Ventricular Tachycardia Clinical Trial

Official title:
A Retrospective Multicenter Post-Market Clinical Follow-up Registry Comparing Safety and Effectiveness Outcomes of Epicardial Cardiac Ablation Using Remote Navigation to Manual Techniques

Clinical Trial 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.

Clinical Trial Description

Up to 10 centers in the European Union will be selected to conduct the trial. Once a site is a selected, receives local Ethics Committee approval, and receives Sponsor approval to enroll, the site will begin enrollment. All subjects must meet eligibility criteria and follow protocol and ethics committee requirements regarding informed consent prior to enrollment. Once a subject is enrolled, the site may begin reviewing the subject's medical records and entering data into the electronic data capture system. Once enrollment and retrospective data entry is complete at a site, a monitoring visit will occur where source data verification will occur. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04171479
Study type Observational
Source Stereotaxis
Contact
Status Completed
Phase
Start date October 2, 2020
Completion date March 30, 2023
View Details
See also
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