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OpenTrials
Completed

NCT Number: NCT04171479

RMN Versus Manual Epicardial Retrospective PMCF

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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Key information

Conditions

Ventricular Tachycardia Arrhythmias, Cardiac Cardiac Complexes, Premature Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Premature Ventricular Contraction Tachycardia Tachycardia, Ventricular Ventricular Premature Complexes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Na Homolce Hospital, Prague, Czechia

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Epicardial mapping and/or ablation

Device

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

Primary outcomes

  1. Acute Success

    Time frame: 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.

  2. Procedural Safety: rates of device-and procedure-related serious adverse events

    Time frame: 48 hours post index procedure

    Assess rates of device-and procedure-related serious adverse events in both groups.

Secondary outcomes

  1. Chronic Success

    Time frame: 1 year post index procedure

    Characterize recurrence rates for both groups at 1 year post index procedure.

  2. Chronic Safety: rates of device-or procedure-related serious adverse events

    Time frame: 1 year post index procedure

    Characterize rates of device-or procedure-related serious adverse events for both groups at 1 year post index procedure.

  3. Mortality

    Time frame: 1 year post index procedure

    Assess mortality rate for both groups

  4. Chronic Success

    Time frame: 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.

  5. Chronic Safety: rates of device-or procedure-related serious adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stereotaxis

Industry

Registry information

Official study 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

Acronym: EPINAV

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 21, 2019
Registry last updated
Aug 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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