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VIVO™ Accuracy Study

Primary Purpose

Premature Ventricular Contraction, Ventricular Tachycardia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VIVO™
Sponsored by
Catheter Precision. Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Premature Ventricular Contraction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Iowa
  • Johns Hopkins Unveristy
  • Medical Unversity of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 3, 2017
Last Updated
November 13, 2018
Sponsor
Catheter Precision. Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03340142
Brief Title
VIVO™ Accuracy Study
Official Title
VIVO™ Accuracy Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 29, 2018 (Actual)
Primary Completion Date
September 4, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catheter Precision. Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ventricular Contraction, Ventricular Tachycardia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
VIVO™
Intervention Description
Diagnose the area of a PVC or VT onset
Primary Outcome Measure Information:
Title
Accuracy of correctly identifying PVC or VT origin
Description
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.
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
Accuracy of correctly identifying known pacing sites
Description
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.
Time Frame
1 Day
Title
Number of adverse events
Description
Monitor adverse events that occur during the procedure followed by a review from the CEC for correlation to VIVO and adjudication if appropriate.
Time Frame
1 Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Missiaen Huck
Organizational Affiliation
Catheter Precision. Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Johns Hopkins Unveristy
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Medical Unversity of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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VIVO™ Accuracy Study

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