VIVO™ Accuracy Study

Catheter Precision. Inc.45 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Premature Ventricular Contraction Ventricular Tachycardia

Interventions

VIVO™DEVICE

Diagnose the area of a PVC or VT onset

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

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

Outcomes

Primary Outcomes

Accuracy of correctly identifying PVC or VT origin

Determine the accuracy of VIVO in identifying a PVC/VT to the left or right ventricle or the septum. The origin, identified by VIVO, will be compared to the Carto system and the successful ablation location.

Time frame: 1 Day

Secondary Outcomes

Accuracy of correctly identifying known pacing sites

Determine the accuracy of VIVO in identifying the location of known pacing sites as compared to the Carto system. The origin, identified by VIVO, will be compared to the location identified by Carto as well as the successful ablation location.

Time frame: 1 Day

Number of adverse events

Monitor adverse events that occur during the procedure followed by a review from the CEC for correlation to VIVO and adjudication if appropriate.

Time frame: 1 Day

Data from ClinicalTrials.gov

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