Ablation at Virtual-hEart pRedicted Targets for VT

NCT03536052 | Completed Results FDA Device

• 1 other identifier: IRB00141401
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Cardiomyopathy; Ventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Ventricular Tachycardia Inducibility

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

  time of procedure

Secondary Outcomes (1)

• Freedom From Ventricular Tachycardia

  1 year

Study Arms (1)

Virtual Heart Guided Ablation

EXPERIMENTAL

Device: Virtual Heart Guided Ablation

Interventions

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.

Virtual Heart Guided Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jonathan Chrispin
• Organization: Johns Hopkins University

chrispin@jhmi.edu

5169848124

Study Officials

• Jonathan Chrispin, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: May 24, 2018
• Study Start: September 26, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 5, 2026
• Results First Posted: February 5, 2026

Record last verified: 2026-02

Locations

US (1)