TerminatedNot Applicable

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

Stopped: Sponsor

United States1 participantsStarted 2021-06-01

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. Participant meets standard criteria for VT ablation and is scheduled for VT ablation by their cardiologist or electrophysiologist
✓. 18 to 85 years of age
✓. VT and ischemic cardiomyopathy
✓. 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
✓. Participant is able and willing to provide written informed consent

Exclusion criteria

✕. Contradiction to MRI (except those with MRI compatible pacemaker/ICD/CRT devices implanted or site has approved procedure for MRI of non-compatible devices).
✕. Participant implanted with an LVAD.
✕. Enrolled in another non-imaging intervention assignment study that could confound the results of this study.

What they're measuring

Time to Receipt of 3D Heart Model

Timeframe: 24 hours

Trial details

NCT IDNCT04841382

SponsorCardioSolv Ablation Technologies

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-10-06

View on ClinicalTrials.gov More Ischemic Monomorphic Ventricular Tachycardia trials