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Completed

NCT Number: NCT03340142

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.

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Key information

Conditions

Premature Ventricular Contraction Arrhythmias, Cardiac Cardiac Complexes, Premature Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Ventricular Premature Complexes Ventricular Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa, Iowa City, Iowa, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VIVO™

Device

Diagnose the area of a PVC or VT onset

Primary outcomes

  1. Accuracy of correctly identifying PVC or VT origin

    Time frame: 1 Day

    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.

Secondary outcomes

  1. Accuracy of correctly identifying known pacing sites

    Time frame: 1 Day

    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.

  2. Number of adverse events

    Time frame: 1 Day

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

Sponsors and collaborators

Lead sponsor

Catheter Precision. Inc.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 13, 2017
Registry last updated
Nov 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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