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OpenTrials
Completed

NCT Number: NCT03536052

Ablation at Virtual-hEart pRedicted Targets for VT

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Heart Guided Ablation

Device

If a good quality cardiac MRI is obtained and a virtual heart model with the ablation targets is generated, the operating physician will merge the virtual heart lesion map to the invasive electroanatomical navigation system. After the patient has been catheterized, an attempt should be made to induce VT. The physician should then navigate the catheter to each of the ablation targets specified, and place a lesion as per his or her training and experience, confirming when done that the lesion marker in the mapping system coincides with the target. This will be done for each lesion.

Primary outcomes

  1. Number of Participants With Ventricular Tachycardia Inducibility

    Time frame: time of procedure

    Following ablation, inducibility of VT will be determined using programmed electrical stimulation

Secondary outcomes

  1. Freedom From Ventricular Tachycardia

    Time frame: 1 year

    Long term Freedom of Spontaneous Ventricular Tachycardia

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Acronym: AVERT-VT

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 24, 2018
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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