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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03536052
Other study ID # IRB00141401
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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