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

University of Pennsylvania

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Cardiovascular Diseases

Interventions

Incorporation of CT and/or c-MRI derived myocardial scar with 3D electroanatomical mapping (EAM).OTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Hospital of The University Of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Major adverse cardiovascular events (MACE)

Incidence of major adverse cardiac events, which are cardiovascular death, myocardial infarction, stroke/TIA

Time frame: 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

Time frame: During the procedure, 24-48 hours after the ablation procedure

Number of Participants Requiring Inotropic support use

Incidence of inotropic and vasoactive agents use

Time frame: 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

Time frame: 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)

Time frame: During procedure, up to 24-48 hours after the ablation procedure

Number of Participants Requiring intubation

Need for intubation

Time frame: During procedure, 24 hours after the ablation procedure

Secondary Outcomes

Experimental procedural duration

Data from ClinicalTrials.gov

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