Back to resultsAblation at Virtual-hEart pRedicted Targets for VT (AVERT-VT)
Primary Purpose
Ventricular Tachycardia, Ischemic Cardiomyopathy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Heart Guided Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Tachycardia
Eligibility Criteria
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.
Sites / Locations
- Johns HopkinsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Virtual Heart Guided Ablation
Arm Description
Outcomes
Primary Outcome Measures
Ventricular Tachycardia Inducibility
Following ablation, inducibility of VT will be determined using programmed electrical stimulation
Secondary Outcome Measures
Freedom from Ventricular Tachycardia
Long term Freedom of Spontaneous Ventricular Tachycardia
Full Information
NCT ID
NCT03536052
First Posted
May 14, 2018
Last Updated
September 25, 2023
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT03536052
Brief Title
Ablation at Virtual-hEart pRedicted Targets for VT
Acronym
AVERT-VT
Official Title
Ablation at Virtual-hEart pRedicted Targets for VT
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia, Ischemic Cardiomyopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Heart Guided Ablation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Virtual Heart Guided Ablation
Intervention Description
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 Outcome Measure Information:
Title
Ventricular Tachycardia Inducibility
Description
Following ablation, inducibility of VT will be determined using programmed electrical stimulation
Time Frame
time of procedure
Secondary Outcome Measure Information:
Title
Freedom from Ventricular Tachycardia
Description
Long term Freedom of Spontaneous Ventricular Tachycardia
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Chrispin, MD
Phone
410-614-6076
Email
chrispin@jhmi.edu
Facility Information:
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Chrispin, MD
Phone
410-614-6076
Email
chrispin@jhmi.edu
12. IPD Sharing Statement
Learn more about this trial
Ablation at Virtual-hEart pRedicted Targets for VT
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