The STandard Versus ImAging SuBstrate Aided Ablation in Severe Left VEntricular
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Pennsylvania
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Number of Participants Requiring Inotropic support use
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Standard of Care Arm
Standard of care procedural steps per respective institution and attending physician's clinical practice.
Imaging-aided VT ablation
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.
Intervention: Incorporation of CT and/or c-MRI derived myocardial scar with 3D electroanatomical mapping (EAM). (Other)
Outcomes
Primary Outcomes
Number of Participants Requiring Inotropic support use
Time Frame: During the procedure, 24-48 hours after the ablation procedure
Incidence of inotropic and vasoactive agents use
Major adverse cardiovascular events (MACE)
Time Frame: during hospital stay following ablation procedure, up to 1 week
Incidence of major adverse cardiac events, which are cardiovascular death, myocardial infarction, stroke/TIA
Number of Participants Requiring Mechanical circulatory support use
Time Frame: During the procedure, 24-48 hours after the ablation procedure
Incidence of mechanical circulatory support (e.g., extra corporeal membrane oxygenation, Impella, LVAD or transplant) use
Number of Participants With Acute kidney injury
Time Frame: During procedure, up to 24-48 hours after the ablation procedure
Acute kidney injury (≥50% within 48 hours of the start of the procedure)
Number of Participants Requiring intubation
Time Frame: During procedure, 24 hours after the ablation procedure
Need for intubation
Number of Participants With Clinically Significant Pericardial Effusion
Time Frame: During the procedure, up to 24 hours after the ablation procedure
Assessing clinically significant pericardial effusion causing hemodynamic instability
Secondary Outcomes
- Time to ventricular tachycardia (VT)(1 year)
- noninvasive programmed stimulation (NIPS) sub-acutely after the procedure(24-48 hours after the procedure.)
- Mean and peak procedural lactate level(During procedure)
- Hospital stay length following the procedure(Periprocedural hospital stay length, up to 2 weeks)
- Left ventricular ejection fraction (LVEF)(6 months after the study)
- Experimental procedural duration(During procedure)
- Left ventricular end-diastolic volume (EDV)(6 months after the study)
- Cumulative procedural inotropic support use(During procedure, 24-48 hours after the ablation procedure)
- Antiarrhythmic Drugs requirement(Through study completion, an average of 1 year)