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Ablation at Virtual-hEart pRedicted Targets for VT (AVERT-VT)

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ClinicalTrials.gov Identifier: NCT03536052
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Ischemic Cardiomyopathy Device: Virtual Heart Guided Ablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ablation at Virtual-hEart pRedicted Targets for VT
Actual Study Start Date : October 20, 2018
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Virtual Heart Guided Ablation 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.




Primary Outcome Measures :
  1. Ventricular Tachycardia Inducibility [ Time Frame: time of procedure ]
    Following ablation, inducibility of VT will be determined using programmed electrical stimulation


Secondary Outcome Measures :
  1. Freedom from Ventricular Tachycardia [ Time Frame: 1 year ]
    Long term Freedom of Spontaneous Ventricular Tachycardia



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536052


Contacts
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Contact: Jonathan Chrispin, MD 410-614-6076 chrispin@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Jonathan Chrispin, MD    410-614-6076    chrispin@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03536052     History of Changes
Other Study ID Numbers: IRB00141401
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Cardiomyopathies
Tachycardia
Tachycardia, Ventricular
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes