Ischemic Monomorphic Ventricular Tachycardia
Conditions
Brief summary
ACE-VT is a clinical pilot study designed to evaluate the ability of the CardioSolv Software System to generate an output for the physician to review in a timely fashion, consistent with the standard of care VT ablation workflow. This study will assess the acute effectiveness of using the CardioSolv Software System output as additional supporting information during ablation.
Interventions
OTHERSupporting information.
CardioSolv Software System is a software-based medical device meant which creates a patient-specific 3D heart model that provides physiologic information.
Sponsors
CardioSolv Ablation Technologies
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Participant meets standard criteria for VT ablation and is scheduled for VT ablation by their cardiologist or electrophysiologist 2. 18 to 85 years of age 3. VT and ischemic cardiomyopathy 4. A pre-procedure MRI with LGE is available (performed within 1 year of procedure, unless an MI has occurred since MRI) with adequate image for analysis 5. Participant is able and willing to provide written informed consent
Exclusion criteria
1. Contradiction to MRI (except those with MRI compatible pacemaker/ICD/CRT devices implanted or site has approved procedure for MRI of non-compatible devices). 2. Participant implanted with an LVAD. 3. Enrolled in another non-imaging intervention assignment study that could confound the results of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Receipt of 3D Heart Model | 24 hours | Verify that the CardioSolv Software System is able to receive and process input data and generate the expected output available for viewing by the physician in less than 24 hours. |
Countries
United States
Outcome results
None listed