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

Ischemic Monomorphic Ventricular Tachycardia Clinical Trial

— ACE-VT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04841382
• Other study ID #: REDD-0018
• Status: Terminated
• Start date: June 1, 2021
• Est. completion date: October 6, 2022

Study information

• Verified date: October 2022
• Source: CardioSolv Ablation Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 6, 2022
• Est. primary completion date: October 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemic Monomorphic Ventricular Tachycardia
• Tachycardia
• Tachycardia, Ventricular

Intervention

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

Locations

Country	Name	City	State
United States	Upenn	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
CardioSolv Ablation Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours