VIVO™ Accuracy Study

Catheter Precision

Status: Completed

Conditions: Premature Ventricular Contraction; Ventricular Tachycardia

Treatments: Device: VIVO™

Study type: Interventional

Funder types: Industry

Identifiers

NCT03340142

94-9001-004

Details and patient eligibility

About

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.

Full 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).

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Single Arm

Experimental group

Description:

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.

Treatment:

Device: VIVO™