- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04219501
Ventricular Arrhythmia Ablation With the Use of Non-Invasive ECG Imaging Technology
March 4, 2021 updated by: Fred Kusumoto, Mayo Clinic
Saving Time During Ventricular Arrhythmia Ablation With the Use of Non-Invasive ECG Imaging Technology
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).
Study Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic in Florida
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
Subjects presenting for PVC/VT ablation will undergo ablation procedures using standard of care invasive electroanatomical mapping systems.
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Experimental: VIVO Arm
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Standard of care invasive electroanatomical mapping system duration
Time Frame: Baseline
|
Total amount of time for standard of care invasive mapping measured in minutes
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Baseline
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VIVO non-invasive mapping system duration
Time Frame: Baseline
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Total amount of time for non-invasive mapping using VIVO measured in minutes
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fred Kusumoto, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 1, 2021
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
January 3, 2020
First Submitted That Met QC Criteria
January 3, 2020
First Posted (Actual)
January 7, 2020
Study Record Updates
Last Update Posted (Actual)
March 8, 2021
Last Update Submitted That Met QC Criteria
March 4, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-007683
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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