Clinical trial NCT04171479: RMN Versus Manual Epicardial Retrospective PMCF
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Tachycardia
Premature Ventricular Contraction
Lead sponsor: Stereotaxis
Sponsor class: INDUSTRY
First posted: 2019-11-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acute Success
timeFrame: intra-operative
measure: Procedural Safety: rates of device-and procedure-related serious adverse events
timeFrame: 48 hours post index procedure
Secondary outcomes:
measure: Chronic Success
timeFrame: 1 year post index procedure
measure: Chronic Safety: rates of device-or procedure-related serious adverse events
timeFrame: 1 year post index procedure
measure: Mortality
timeFrame: 1 year post index procedure
measure: Chronic Success
timeFrame: At last follow up visit, estimated up to 6 years post-procedure for some patients
measure: Chronic Safety: rates of device-or procedure-related serious adverse events
timeFrame: At last follow up visit, estimated up to 6 years post-procedure for some patients
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Amsterdam
country: Netherlands
facility: OLVG Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
References: