RMN Versus Manual Epicardial Retrospective PMCF

Status Completed

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

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See also
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RMN Versus Manual Epicardial Retrospective PMCF — EPINAV

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms