VIVO™ Accuracy Study

Completed · Not applicable

Conditions studied: Premature Ventricular Contraction, Ventricular Tachycardia

In brief

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.

Key facts

Study ID

NCT03340142

Run by

Catheter Precision. Inc.

People needed

45

Starts

2018-01-29

Expected to finish

2018-11-01

Last updated by the study team

2018-11-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Iowa — Iowa City, Iowa, United States
• Johns Hopkins Unveristy — Baltimore, Maryland, United States
• Medical Unversity of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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