Back to resultsVentricular Arrhythmia Ablation With the Use of Non-Invasive ECG Imaging Technology
Primary Purpose
Premature Ventricular Contraction, Ventricular Tachycardia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VIVO
Sponsored by
About this trial
This is an interventional health services research trial for Premature Ventricular Contraction
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age
- Structurally normal heart
- Cardiac MRI/CT as part of standard of care
- Diagnosed with premature ventricular contractions or ventricular tachycardia and scheduled to undergo an ablation to treat these conditions
Exclusion Criteria:
- Less than 18 years of age
- Structurally abnormal heart
Sites / Locations
- Mayo Clinic in Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
VIVO Arm
Arm Description
Subjects presenting for PVC/VT ablation will undergo ablation procedures using standard of care invasive electroanatomical mapping systems.
Subjects presenting for PVC/VT ablation, that have a previously acquired cardiac CT/MRI scan or are having a cardiac CT/MRI scan as per routine care, will undergo ablation procedures using VIVO, a novel, non-invasive mapping system.
Outcomes
Primary Outcome Measures
Standard of care invasive electroanatomical mapping system duration
Total amount of time for standard of care invasive mapping measured in minutes
VIVO non-invasive mapping system duration
Total amount of time for non-invasive mapping using VIVO measured in minutes
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04219501
Brief Title
Ventricular Arrhythmia Ablation With the Use of Non-Invasive ECG Imaging Technology
Official Title
Saving Time During Ventricular Arrhythmia Ablation With the Use of Non-Invasive ECG Imaging Technology
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Mutual decision between the investigators and the sponsor
Study Start Date
February 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Researchers are trying to determine if the use of software called VIVO, made by Catheter Precision, Inc. can shorten the length of time it takes to perform an ablation procedure for either premature ventricular contractions (PVCs) and ventricular tachycardia (VT).
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
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Subjects presenting for PVC/VT ablation will undergo ablation procedures using standard of care invasive electroanatomical mapping systems.
Arm Title
VIVO Arm
Arm Type
Experimental
Arm Description
Subjects presenting for PVC/VT ablation, that have a previously acquired cardiac CT/MRI scan or are having a cardiac CT/MRI scan as per routine care, will undergo ablation procedures using VIVO, a novel, non-invasive mapping system.
Intervention Type
Other
Intervention Name(s)
VIVO
Intervention Description
Non-invasive mapping system software product that combines patient-specific images (MRI or CT) of the torso and cardiac structures and a 3D image of the torso that identifies precise ECG lead placement to generate a 3D model of the patient's heart.
Primary Outcome Measure Information:
Title
Standard of care invasive electroanatomical mapping system duration
Description
Total amount of time for standard of care invasive mapping measured in minutes
Time Frame
Baseline
Title
VIVO non-invasive mapping system duration
Description
Total amount of time for non-invasive mapping using VIVO measured in minutes
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age
Structurally normal heart
Cardiac MRI/CT as part of standard of care
Diagnosed with premature ventricular contractions or ventricular tachycardia and scheduled to undergo an ablation to treat these conditions
Exclusion Criteria:
Less than 18 years of age
Structurally abnormal heart
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fred Kusumoto, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Ventricular Arrhythmia Ablation With the Use of Non-Invasive ECG Imaging Technology
We'll reach out to this number within 24 hrs