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Ablation at Virtual-hEart pRedicted Targets for VT (AVERT-VT)

Johns Hopkins University logo

Johns Hopkins University

Status

Completed

Conditions

Ischemic Cardiomyopathy
Ventricular Tachycardia

Treatments

Device: Virtual Heart Guided Ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT03536052
IRB00141401

Details and patient eligibility

About

The goal of this study is to test the efficacy of the new imaging/simulation ("virtual heart") approach for determining the optimal ablation sites in patients with VT, which render post-infarction VT non-inducible. The study will test both the acute outcome of the ablation procedure, and the effect the use of the predicted targets has upon procedure time.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Eligible patients must be at least 18 years old at the time of enrollment.
  • A Pre-Op cardiac MRI including late gadolinium enhancement (LGE) must be performed prior to ablation. As Johns Hopkins University (JHU) performs MRIs with implantable cardioverter defibrillator (ICD) or pacemaker implanted, patients with these devices may be enrolled.
  • Eligible patients must suffer from VT, thought to be secondary to structural heart disease (scarring).
  • Eligible patients must be determined to be suitable candidates for ablation to treat VT by their cardiologist and/or electrophysiologists regardless of this protocol.

Exclusion criteria

  • Patients with Glomerular Filtration Rate (GFR) < 30 mL/min should not be enrolled in the study due to the use of intravenous gadolinium as an MRI contrast agent
  • If a pre-procedure MRI cannot or likely will not be performed for any reason (such as claustrophobia), the patient must be excluded.
  • Pregnant women may not participate in the study because gadolinium MRI contrast is contraindicated in these patients.
  • Any subject that, during the course of the pre-procedure imaging, is discovered to have VT not related to scarring, he/she must be de-enrolled from the study.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Virtual Heart Guided Ablation
Experimental group
Treatment:
Device: Virtual Heart Guided Ablation

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Jonathan Chrispin, MD

Data sourced from clinicaltrials.gov

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