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

Terminated

• Conditions: Ischemic Monomorphic Ventricular Tachycardia

• Registration Number: NCT04841382
• Lead Sponsor: CardioSolv Ablation Technologies

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-08
• Study First Posted: 2021-04-12
• Study Start: 2021-06-01
• Status Verified: 2022-10
• Primary Completion: 2022-10-06
• Study Completion: 2022-10-06
• Last Update Submitted: 2022-10-17
• Last Update Posted: 2022-10-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Upenn; 🇺🇸 Philadelphia, Pennsylvania, United States