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Mutual decision between the investigators and the sponsor
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Subjects presenting for PVC/VT ablation will undergo ablation procedures using standard of care invasive electroanatomical mapping systems. | |
| VIVO Arm | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIVO | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Standard of care invasive electroanatomical mapping system duration | Total amount of time for standard of care invasive mapping measured in minutes | Baseline |
| VIVO non-invasive mapping system duration | Total amount of time for non-invasive mapping using VIVO measured in minutes | Baseline |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fred Kusumoto, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D018879 | Ventricular Premature Complexes |
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D005117 | Cardiac Complexes, Premature |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |