The STandard Versus ImAging SuBstrate Aided Ablation in Severe Left VEntricular Dysfunction VT.
- Conditions
- Cardiovascular Diseases
- Interventions
- Other: Incorporation of CT and/or c-MRI derived myocardial scar with 3D electroanatomical mapping (EAM).
- Registration Number
- NCT05828667
- Lead Sponsor
- University of Pennsylvania
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Imaging-aided VT ablation Incorporation of CT and/or c-MRI derived myocardial scar with 3D electroanatomical mapping (EAM). 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.
- Primary Outcome Measures
Name Time Method Number of Participants Requiring Inotropic support use During the procedure, 24-48 hours after the ablation procedure Incidence of inotropic and vasoactive agents use
Major adverse cardiovascular events (MACE) 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 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 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 During procedure, 24 hours after the ablation procedure Need for intubation
Number of Participants With Clinically Significant Pericardial Effusion During the procedure, up to 24 hours after the ablation procedure Assessing clinically significant pericardial effusion causing hemodynamic instability
- Secondary Outcome Measures
Name Time Method Time to ventricular tachycardia (VT) 1 year Time to recurrent VT or censoring at 1 year (detection 10 bpm \< rate of slowest VT)
noninvasive programmed stimulation (NIPS) sub-acutely after the procedure 24-48 hours after the procedure. comparable freedom from VT at noninvasive programmed stimulation (NIPS) sub-acutely after the procedure and at two-year follow-up.
Mean and peak procedural lactate level During procedure Mean and peak procedural lactate level
Hospital stay length following the procedure Periprocedural hospital stay length, up to 2 weeks Hospital stay length following the procedure
Left ventricular ejection fraction (LVEF) 6 months after the study Change in LVEF at 6 months at regular clinic follow-ups following the procedure
Experimental procedural duration During procedure Experimental procedural duration
Left ventricular end-diastolic volume (EDV) 6 months after the study Change in EDV at 6 months at regular clinic follow-ups following the procedure
Cumulative procedural inotropic support use During procedure, 24-48 hours after the ablation procedure Cumulative procedural inotropic support use
Antiarrhythmic Drugs requirement Through study completion, an average of 1 year Antiarrhythmic Drugs requirement following the procedure
Trial Locations
- Locations (1)
Hospital of The University Of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States