VIVO™ Accuracy Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Catheter Precision. Inc.
- Enrollment
- 45
- Locations
- 3
- Primary Endpoint
- Accuracy of correctly identifying PVC or VT origin
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •Active infection
- •Pregnancy: Females of childbearing potential with a positive pregnancy test.
- •Existing mechanical heart valve
Arms & Interventions
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.
Intervention: VIVO™ (Device)
Outcomes
Primary Outcomes
Accuracy of correctly identifying PVC or VT origin
Time Frame: 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 Outcomes
- Accuracy of correctly identifying known pacing sites(1 Day)
- Number of adverse events(1 Day)