Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual | Subjects who underwent epicardial mapping and/or ablation using a manual technique will comprise this group. |
| |
| Remote Magnetic Navigation | Subjects who underwent epicardial mapping and/or ablation using a remote magnetic technique (using Stereotaxis Niobe system) will comprise this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epicardial mapping and/or ablation | Device | Either catheter mapping, ablation, or mapping and ablation will be performed using an epicardial catheter approach. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Subjects who have undergone an epicardial cardiac mapping and ablation procedure using either manual or remote magnetic (using Stereotaxis Niobe system) guidance.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Na Homolce Hospital | Prague | Czechia | ||||
| OLVG Hospital |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D018879 | Ventricular Premature Complexes |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| Amsterdam |
| Netherlands |
| Erasmus Medical Center | Rotterdam | Netherlands |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005117 | Cardiac Complexes, Premature |