VIVO™ Accuracy Study
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/17/2018 |
Start Date: | January 29, 2018 |
End Date: | November 1, 2018 |
A multi-center study designed to assess the accuracy of VIVO™ in determining the location of
a PVC/VT foci in comparison to an electroanatomical mapping system.
a PVC/VT foci in comparison to an electroanatomical mapping system.
The VIVO accuracy study will assess the accuracy of locating a PVC/VT foci by pacing known
anatomical locations and comparing the VIVO outcome to that of the Carto system
(Biosense-Webster).
anatomical locations and comparing the VIVO outcome to that of the Carto system
(Biosense-Webster).
Inclusion Criteria:
- Subjects who are at least 18 years or older
- Subjects who are scheduled for PVC/VT ablation procedure with structurally normal
hearts and less than 10% scar.
- Subjects who have signed an IRB/EC approved Informed Consent Form and applicable
subject privacy protection authorization per local law
- Subjects will be selected without regard to gender or age (unless precluded by local
regulatory requirements)
Exclusion Criteria:
- Subjects who are contraindicated for CT or MRI (must be able to get one)
- Subject whose MRI or CT scan does not comply with the requirements of this protocol
- Subjects who are contraindicated for an electrophysiology procedure and/or
fluoroscopy:
- INR > 3
- Active infection
- Pregnancy: Females of childbearing potential with a positive pregnancy test.
- Existing mechanical heart valve
We found this trial at
3
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University of Iowa With just over 30,000 students, the University of Iowa is one of...
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