Physician Assessment of the Clinical Utility of a Patient-Specific 3D Electro-Anatomical Heart Model in VT Ablation

CardioSolv Ablation Technologies1 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ischemic Monomorphic Ventricular Tachycardia

Interventions

Supporting information.OTHER

CardioSolv Software System is a software-based medical device meant which creates a patient-specific 3D heart model that provides physiologic information.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Upenn

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Time to Receipt of 3D Heart Model

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.

Time frame: 24 hours

Data from ClinicalTrials.gov

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