Ablation at Virtual-hEart pRedicted Targets for VT

Ventricular Tachycardia Clinical Trial

— AVERT-VT  

Official title:

Ablation at Virtual-hEart pRedicted Targets for VT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03536052
• Other study ID #: IRB00141401
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: September 2023
• Source: Johns Hopkins University
• Contact: Jonathan Chrispin, MD
• Phone: 410-614-6076
• Email: chrispin[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Ischemic Cardiomyopathy
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Device:
• Virtual Heart Guided Ablation
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.

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventricular Tachycardia Inducibility	Following ablation, inducibility of VT will be determined using programmed electrical stimulation	time of procedure
Secondary	Freedom from Ventricular Tachycardia	Long term Freedom of Spontaneous Ventricular Tachycardia	1 year