RMN Versus Manual Epicardial Retrospective PMCF

Study Overview
=================
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.

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

Conditions
-----------------
Ventricular Tachycardia, Premature Ventricular Contraction

Intervention / Treatment
-----------------
* Device: Epicardial mapping and/or ablation


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Manual<br>Subjects who underwent epicardial mapping and/or ablation using a manual technique will comprise this group. | Device: Epicardial mapping and/or ablation<br>* Either catheter mapping, ablation, or mapping and ablation will be performed using an epicardial catheter approach.<br>|
| Remote Magnetic Navigation<br>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<br>* Either catheter mapping, ablation, or mapping and ablation will be performed using an epicardial catheter approach.<br>|

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 |