VIVO™ Accuracy Study

Ventricular Tachycardia Clinical Trial

Official title:

VIVO™ Accuracy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03340142
• Other study ID #: 94-9001-004
• Status: Completed
• Phase: N/A
• Start date: January 29, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: November 2018
• Source: Catheter Precision. Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 1, 2018
• Est. primary completion date: September 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Ventricular Contraction
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Premature Complexes
• Ventricular Tachycardia

Intervention

Device:
• VIVO™
Diagnose the area of a PVC or VT onset

Locations

Country	Name	City	State
United States	Johns Hopkins Unveristy	Baltimore	Maryland
United States	Medical Unversity of South Carolina	Charleston	South Carolina
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Catheter Precision. Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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