Premature Ventricular Contraction, Ventricular Tachycardia
Conditions
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.
Interventions
DEVICEEpicardial mapping and/or ablation
Either catheter mapping, ablation, or mapping and ablation will be performed using an epicardial catheter approach.
Sponsors
Stereotaxis
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Success | 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. |
| Procedural Safety: rates of device-and procedure-related serious adverse events | 48 hours post index procedure | Assess rates of device-and procedure-related serious adverse events in both groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic Success | 1 year post index procedure | Characterize recurrence rates for both groups at 1 year post index procedure. |
| Chronic Safety: rates of device-or procedure-related serious adverse events | 1 year post index procedure | Characterize rates of device-or procedure-related serious adverse events for both groups at 1 year post index procedure. |
| Mortality | 1 year post index procedure | Assess mortality rate for both groups |
Countries
Czechia, Netherlands
Outcome results
None listed