An observational study in Ventricular Tachycardia and Premature Ventricular Contraction, sponsored by Stereotaxis. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-03.
Sponsored by Stereotaxis · Observational
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.
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.
451 studies on the registry are indexed under Tachycardia, Ventricular; 120 are open to participants now.
This study's enrollment of 40 is below the median of 167 across 147 observational studies indexed under Tachycardia, Ventricular.
Browse Tachycardia, Ventricular studies →Stereotaxis is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects who have undergone an epicardial cardiac mapping and ablation procedure using either manual or remote magnetic (using Stereotaxis Niobe system) guidance.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects who underwent epicardial mapping and/or ablation using a manual technique will comprise this group.
Device: Epicardial mapping and/or ablation
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
Either catheter mapping, ablation, or mapping and ablation will be performed using an epicardial catheter approach.
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.
Time frame: 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.
Time frame: 48 hours post index procedure
Chronic Success
Characterize recurrence rates for both groups at 1 year post index procedure.
Time frame: 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.
Time frame: 1 year post index procedure
Mortality
Assess mortality rate for both groups
Time frame: 1 year post index procedure
Chronic Success
Characterize recurrence rates for both groups at last follow up.
Time frame: 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.
Time frame: At last follow up visit, estimated up to 6 years post-procedure for some patients
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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