Cardiovascular Diseases
Conditions
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.
Interventions
OTHERIncorporation of CT and/or c-MRI derived myocardial scar with 3D electroanatomical mapping (EAM).
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.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A randomized controlled non-blinded prospective single-center study
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Requiring Inotropic support use | During the procedure, 24-48 hours after the ablation procedure | Incidence of inotropic and vasoactive agents use |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to ventricular tachycardia (VT) | 1 year | Time to recurrent VT or censoring at 1 year (detection 10 bpm \< rate of slowest VT) |
| Antiarrhythmic Drugs requirement | Through study completion, an average of 1 year | Antiarrhythmic Drugs requirement following the procedure |
| Hospital stay length following the procedure | Periprocedural hospital stay length, up to 2 weeks | Hospital stay length following the procedure |
| Experimental procedural duration | During procedure | Experimental procedural duration |
| 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 |
| Cumulative procedural inotropic support use | During procedure, 24-48 hours after the ablation procedure | Cumulative procedural inotropic support use |
| Left ventricular ejection fraction (LVEF) | 6 months after the study | Change in LVEF at 6 months at regular clinic follow-ups following the procedure |
| 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 |
Countries
United States
Outcome results
None listed