VIVO™ Accuracy Study

NCT ID: NCT03340142

Last Updated: 2018-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-29

Study Completion Date

2018-11-01

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Premature Ventricular Contraction Ventricular Tachycardia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single Arm

All patients will undergo standard of care ablation procedures. VIVO™ results will be compared to that of standard of care results, but will not be used in diagnosis or treatment.

Group Type EXPERIMENTAL

VIVO™

Intervention Type DEVICE

Diagnose the area of a PVC or VT onset

Interventions

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VIVO™

Diagnose the area of a PVC or VT onset

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catheter Precision. Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Missiaen Huck

Role: STUDY_DIRECTOR

Catheter Precision. Inc.

Locations

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University of Iowa

Iowa City, Iowa, United States

Site Status

Johns Hopkins Unveristy

Baltimore, Maryland, United States

Site Status

Medical Unversity of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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94-9001-004

Identifier Type: -

Identifier Source: org_study_id

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