RMN Versus Manual Epicardial Retrospective PMCF (EPINAV)

A Retrospective Multicenter Post-Market Clinical Follow-up Registry Comparing Safety and Effectiveness Outcomes of Epicardial Cardiac Ablation Using Remote Navigation to Manual Techniques

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.

Study Overview

• Status: Completed
• Conditions: Ventricular Tachycardia; Premature Ventricular Contraction
• Intervention / Treatment: Device: Epicardial mapping and/or ablation

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

• Study Contact: Name: Stephanie Buech; Phone Number: 1-314-678-6100; Email: Stephanie.Buech@stereotaxis.com

Study Locations

• Czechia
  • Prague, Czechia
    • Na Homolce Hospital
• Netherlands
  • Amsterdam, Netherlands
    • OLVG Hospital
  • Rotterdam, Netherlands
    • Erasmus Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects who have undergone an epicardial cardiac mapping and ablation procedure using either manual or remote magnetic (using Stereotaxis Niobe system) guidance.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Manual; Subjects who underwent epicardial mapping and/or ablation using a manual technique will comprise this group.	Device: Epicardial mapping and/or ablation; 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.	Device: Epicardial mapping and/or ablation; Either catheter mapping, ablation, or mapping and ablation will be performed using an epicardial catheter approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Success	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.	intra-operative
Procedural Safety: rates of device-and procedure-related serious adverse events	Assess rates of device-and procedure-related serious adverse events in both groups.	48 hours post index procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stereotaxis

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2020
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Cardiac Complexes, Premature; Tachycardia; Tachycardia, Ventricular; Ventricular Premature Complexes
• Other Study ID Numbers: CLIN-024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes