NCT04171479

RMN Versus Manual Epicardial Retrospective PMCF

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
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Stereotaxis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Ventricular Tachycardia
• Premature Ventricular Contraction

Interventions

Type	Name	Description
DEVICE	Epicardial mapping and/or ablation	Either catheter mapping, ablation, or mapping and ablation will be performed using an epicardial catheter approach.

Timeline

• Start date: 2020-10-02
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2019-11-21
• Last updated: 2023-08-03

Locations

3 sites across 2 countries: Czechia, Netherlands

Regulatory

• FDA-regulated device study