Ablation at Virtual-hEart pRedicted Targets for VT

Not Applicable

Active, not recruiting

• Conditions: Ischemic Cardiomyopathy; Ventricular Tachycardia
• Interventions: Device: Virtual Heart Guided Ablation

• Registration Number: NCT03536052
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-14
• Study First Submitted QC: 2018-05-14
• Study First Posted: 2018-05-24
• Study Start: 2022-09-26
• Status Verified: 2025-01
• Primary Completion: 2025-01-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual Heart Guided Ablation	Virtual Heart Guided Ablation	-

Primary Outcome Measures

Name	Time	Method
Ventricular Tachycardia Inducibility	time of procedure	Following ablation, inducibility of VT will be determined using programmed electrical stimulation

Secondary Outcome Measures

Name	Time	Method
Freedom from Ventricular Tachycardia	1 year	Long term Freedom of Spontaneous Ventricular Tachycardia

Trial Locations

Locations (1)

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States