The STandard Versus ImAging SuBstrate Aided Ablation in Severe Left VEntricular Dysfunction VT. (STABLE-VT)

University of Pennsylvania

Status: Withdrawn

Conditions: Cardiovascular Diseases

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05828667

851281

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Standard of Care Arm

No Intervention group

Description:

Standard of care procedural steps per respective institution and attending physician's clinical practice.

Imaging-aided VT ablation

Experimental group

Description:

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.

Treatment:

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