Status:
COMPLETED
VIVO™ Accuracy Study
Lead Sponsor:
Catheter Precision. Inc.
Conditions:
Premature Ventricular Contraction
Ventricular Tachycardia
Eligibility:
All Genders
18+ years
Phase:
NA
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03340142
Start Date
January 29 2018
End Date
November 1 2018
Last Update
November 15 2018
Active Locations (3)
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1
University of Iowa
Iowa City, Iowa, United States, 52242
2
Johns Hopkins Unveristy
Baltimore, Maryland, United States, 21287
3
Medical Unversity of South Carolina
Charleston, South Carolina, United States, 29425