RMN Versus Manual Epicardial Retrospective PMCF

Ventricular Tachycardia Clinical Trial

— EPINAV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04171479
• Other study ID #: CLIN-024
• Status: Completed
• Start date: October 2, 2020
• Est. completion date: March 30, 2023

Study information

• Verified date: August 2023
• Source: Stereotaxis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Premature Ventricular Contraction
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Premature Complexes
• Ventricular Tachycardia

Intervention

Device:
• Epicardial mapping and/or ablation
Either catheter mapping, ablation, or mapping and ablation will be performed using an epicardial catheter approach.

Locations

Country	Name	City	State
Czechia	Na Homolce Hospital	Prague
Netherlands	OLVG Hospital	Amsterdam
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Stereotaxis

Countries where clinical trial is conducted

Czechia,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Chronic Success	Characterize recurrence rates for both groups at 1 year post index procedure.	1 year post index procedure
Secondary	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
Secondary	Mortality	Assess mortality rate for both groups	1 year post index procedure
Secondary	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
Secondary	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