VIVO™ Accuracy Study

NCT03340142 | Completed FDA Device

• 1 other identifier: 94-9001-004
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Premature Ventricular Contraction; Ventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Accuracy of correctly identifying known pacing sites

  1 Day

• Number of adverse events

  1 Day

Study Arms (1)

Single Arm

EXPERIMENTAL

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™

Interventions

VIVO™ DEVICE

Diagnose the area of a PVC or VT onset

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Catheter Precision. Inc.: lead

Study Sites (3)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Johns Hopkins Unveristy

Baltimore, Maryland, 21287, United States

Location

Medical Unversity of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Ventricular Premature Complexes; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

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

Study Officials

• Missiaen Huck

  Catheter Precision. Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 13, 2017
• Study Start: January 29, 2018
• Primary Completion: September 4, 2018
• Study Completion: November 1, 2018
• Last Updated: November 15, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)