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

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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.

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).

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
sites
101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Baltimore, Maryland 21287
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Charleston, South Carolina 29425
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