The STandard Versus ImAging SuBstrate Aided Ablation in Severe Left VEntricular Dysfunction VT.

Study Overview
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Brief Summary
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The STABLE-VT trial aims to determine the safety profile and clinical efficacy of a modified approach to ventricular tachycardia (VT) ablation that integrates myocardial scar as visualized on cardiac magnetic resonance (c-MRI) or CT into electroanatomical mapping (EAM) for VT ablation.

Detailed Description
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The STABLE-VT trial aims to integrate myocardial scar as visualized on cardiac magnetic resonance (c-MRI) or CT into electroanatomical mapping (EAM) for VT ablation. Particularly, we will compare the procedural safety, and acute and long-term clinical efficacy of this imaging-aided VT ablation protocol to standard of care. Our hypothesis is that patients with ventricular tachycardia (VT) and severe LV dysfunction randomized to this imaging-aided protocol will have shorter procedure duration, improved procedural hemodynamic stability, fewer acute major adverse cardiovascular events (MACE), less need for mechanical support, comparable freedom from VT at noninvasive programmed stimulation (NIPS) sub-acutely after the procedure, and at two-year follow-up compared to standard ablation approach. Herein, our outcomes of interest will be captured during the two years following as part of regular standard of care follow-ups.

Official Title
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The STandard Versus ImAging SuBstrate Aided Ablation in Severe Left VEntricular

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Other: Incorporation of CT and/or c-MRI derived myocardial scar with 3D electroanatomical mapping (EAM).


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients (>18 years old) diagnosed with severely reduced ejection fraction defined as EF≤25% or EF≤ 35% with concurrent NYHA class III/IV heart failure symptoms and/or at least one previous heart failure hospitalization in the previous 6 months) who are referred for VT ablation. Patients with moderate to severe RV dysfunction diagnosed on most recent imaging (echo/c-MRI). Patients with must have undergone the imaging (c-MRI and/or CT) required for the investigational VT approach to qualify for participation. Exclusion Criteria: Patients in whom Impella/ECMO or anesthesia is indicated prior to or at presentation to the EP lab. Patients for whom an informed consent cannot be obtained. Patients who are found to be pregnant using detection of human chorionic gonadotropin (hcg) as done as part of standard of care, will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized controlled non-blinded prospective single-center study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care Arm<br>Standard of care procedural steps per respective institution and attending physician's clinical practice. | |
| Experimental: Imaging-aided VT ablation<br>For subjects assigned to the imaging-aided VT ablation arm, CT and/or c-MRI derived myocardial scar will be merged with 3D electroanatomical mapping (EAM) prior to the ablation to allow for readily localization and characterization of VT substrates and potential re-entry circuits to be ablated. This integrated mapping of VT substrates sites to be ablated will be given to the electrophysiologist prior to the ablation. | Other: Incorporation of CT and/or c-MRI derived myocardial scar with 3D electroanatomical mapping (EAM).<br>* CT and/or c-MRI derived myocardial scar will be merged with 3D electroanatomical mapping (EAM) prior to the ablation to allow for readily localization and characterization of VT substrates and potential re-entry circuits to be ablated. This is done with the intent to limit the repeated number of inductions and prolonged point-by-point voltage mapping that often result in hemodynamic instability.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events (MACE) | Incidence of major adverse cardiac events, which are cardiovascular death, myocardial infarction, stroke/TIA | during hospital stay following ablation procedure, up to 1 week | 
| Number of Participants Requiring Mechanical circulatory support use | Incidence of mechanical circulatory support (e.g., extra corporeal membrane oxygenation, Impella, LVAD or transplant) use | During the procedure, 24-48 hours after the ablation procedure | 
| Number of Participants Requiring Inotropic support use | Incidence of inotropic and vasoactive agents use | During the procedure, 24-48 hours after the ablation procedure | 
| Number of Participants With Clinically Significant Pericardial Effusion | Assessing clinically significant pericardial effusion causing hemodynamic instability | During the procedure, up to 24 hours after the ablation procedure | 
| Number of Participants With Acute kidney injury | Acute kidney injury (≥50% within 48 hours of the start of the procedure) | During procedure, up to 24-48 hours after the ablation procedure | 
| Number of Participants Requiring intubation | Need for intubation | During procedure, 24 hours after the ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experimental procedural duration | Experimental procedural duration | During procedure | 
| noninvasive programmed stimulation (NIPS) sub-acutely after the procedure | comparable freedom from VT at noninvasive programmed stimulation (NIPS) sub-acutely after the procedure and at two-year follow-up. | 24-48 hours after the procedure. | 
| Mean and peak procedural lactate level | Mean and peak procedural lactate level | During procedure | 
| Cumulative procedural inotropic support use | Cumulative procedural inotropic support use | During procedure, 24-48 hours after the ablation procedure | 
| Hospital stay length following the procedure | Hospital stay length following the procedure | Periprocedural hospital stay length, up to 2 weeks | 
| Time to ventricular tachycardia (VT) | Time to recurrent VT or censoring at 1 year (detection 10 bpm < rate of slowest VT) | 1 year | 
| Antiarrhythmic Drugs requirement | Antiarrhythmic Drugs requirement following the procedure | Through study completion, an average of 1 year | 
| Left ventricular ejection fraction (LVEF) | Change in LVEF at 6 months at regular clinic follow-ups following the procedure | 6 months after the study | 
| Left ventricular end-diastolic volume (EDV) | Change in EDV at 6 months at regular clinic follow-ups following the procedure | 6 months after the study |