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.

Study Overview

• Status: Completed
• Conditions: Ventricular Tachycardia; Premature Ventricular Contraction
• Intervention / Treatment: Device: VIVO™

Detailed Description

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
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Unveristy
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical Unversity of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: VIVO™; Diagnose the area of a PVC or VT onset

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 Day

Collaborators and Investigators

• Sponsor: Catheter Precision. Inc.
• Investigators: Study Director: Missiaen Huck, Catheter Precision. Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2018
• Primary Completion (Actual): September 4, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: November 3, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Cardiac Complexes, Premature; Tachycardia; Tachycardia, Ventricular; Ventricular Premature Complexes
• Other Study ID Numbers: 94-9001-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes