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VIVO™ Accuracy Study | Clinical Trials | Clareo Health

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COMPLETEDNANCT03340142

VIVO™ Accuracy Study

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.

Lead sponsor: Catheter Precision. Inc.•3 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Catheter Precision. Inc.

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).

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 15, 2018Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment45

Start dateJan 2018

Last updatedNov 15, 2018

Condition

Premature Ventricular Contraction Ventricular Tachycardia

Locations shown

University of Iowa

Iowa City, Iowa

Johns Hopkins Unveristy

Baltimore, Maryland

Medical Unversity of South Carolina

Charleston, South Carolina

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 15, 2018Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions