RMN Versus Manual Epicardial Retrospective PMCF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-02

Study Completion Date

2023-03-30

Brief Summary

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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.

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Detailed Description

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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

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Ventricular Tachycardia Premature Ventricular Contraction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Manual

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

Epicardial mapping and/or ablation

Intervention Type DEVICE

Either catheter mapping, ablation, or mapping and ablation will be performed using an epicardial catheter approach.

Remote Magnetic Navigation

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

Epicardial mapping and/or ablation

Intervention Type DEVICE

Either catheter mapping, ablation, or mapping and ablation will be performed using an epicardial catheter approach.

Interventions

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Epicardial mapping and/or ablation

Either catheter mapping, ablation, or mapping and ablation will be performed using an epicardial catheter approach.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No