RMN Versus Manual Epicardial Retrospective PMCF (EPINAV)

Stereotaxis

Status: Completed

Conditions: Premature Ventricular Contraction; Ventricular Tachycardia

Treatments: Device: Epicardial mapping and/or ablation

Study type: Observational

Funder types: Industry

Identifiers

NCT04171479

CLIN-024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• NA, all subjects who meet inclusion criteria may be enrolled.

Trial design

40 participants in 2 patient groups

Manual

Description:

Subjects who underwent epicardial mapping and/or ablation using a manual technique will comprise this group.

Treatment:

Device: Epicardial mapping and/or ablation

Remote Magnetic Navigation

Description:

Subjects who underwent epicardial mapping and/or ablation using a remote magnetic technique (using Stereotaxis Niobe system) will comprise this group.

Treatment:

Device: Epicardial mapping and/or ablation