VIVO™ Accuracy Study

Not Applicable

Completed

• Conditions: Ventricular Tachycardia; Premature Ventricular Contraction
• Interventions: Device: VIVO™

• Registration Number: NCT03340142
• Lead Sponsor: Catheter Precision. Inc.

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.

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 Timeline

• Study First Submitted: 2017-11-03
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-13
• Study Start: 2018-01-29
• Primary Completion: 2018-09-04
• Status Verified: 2018-11
• Study Completion: 2018-11-01
• Last Update Submitted: 2018-11-13
• Last Update Posted: 2018-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	VIVO™	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.

Primary Outcome Measures

Name	Time	Method
Accuracy of correctly identifying PVC or VT origin	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 Outcome Measures

Name	Time	Method
Accuracy of correctly identifying known pacing sites	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.
Number of adverse events	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.

Trial Locations

Locations (3)

Medical Unversity of South Carolina; 🇺🇸 Charleston, South Carolina, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Johns Hopkins Unveristy; 🇺🇸 Baltimore, Maryland, United States