RMN Versus Manual Epicardial Retrospective PMCF

Completed

• Conditions: Ventricular Tachycardia; Premature Ventricular Contraction
• Interventions: Device: Epicardial mapping and/or ablation

• Registration Number: NCT04171479
• Lead Sponsor: Stereotaxis

Brief 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.

Study Timeline

• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Study Start: 2020-10-02
• Primary Completion: 2023-03-30
• Study Completion: 2023-03-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Remote Magnetic Navigation	Epicardial mapping and/or ablation	Subjects who underwent epicardial mapping and/or ablation using a remote magnetic technique (using Stereotaxis Niobe system) will comprise this group.
Manual	Epicardial mapping and/or ablation	Subjects who underwent epicardial mapping and/or ablation using a manual technique will comprise this group.

Primary Outcome Measures

Name	Time	Method
Procedural Safety: rates of device-and procedure-related serious adverse events	48 hours post index procedure	Assess rates of device-and procedure-related serious adverse events in both groups.
Acute Success	intra-operative	Characterize acute success rates for both groups. Acute success for VT procedures is defined as non-inducibility of clinical VT and/or other monomorphic VT at the end of the index-procedure. Acute success for PVC procedures is defined as no recurrence and non-inducibility of culprit PVC at the end of the index-procedure.

Secondary Outcome Measures

Name	Time	Method
Mortality	1 year post index procedure	Assess mortality rate for both groups
Chronic Safety: rates of device-or procedure-related serious adverse events	At last follow up visit, estimated up to 6 years post-procedure for some patients	Characterize rates of device-or procedure-related serious adverse events for both groups at last follow up.
Chronic Success	At last follow up visit, estimated up to 6 years post-procedure for some patients	Characterize recurrence rates for both groups at last follow up.

Trial Locations

Locations (3)

OLVG Hospital; 🇳🇱 Amsterdam, Netherlands

Na Homolce Hospital; 🇨🇿 Prague, Czechia

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands