Clinical trial NCT05828667: The STandard Versus ImAging SuBstrate Aided Ablation in Severe Left VEntricular Dysfunction VT.
Official title: The STandard Versus ImAging SuBstrate Aided Ablation in Severe Left VEntricular
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled non-blinded prospective single-center study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Major adverse cardiovascular events (MACE)
timeFrame: during hospital stay following ablation procedure, up to 1 week
measure: Number of Participants Requiring Mechanical circulatory support use
timeFrame: During the procedure, 24-48 hours after the ablation procedure
measure: Number of Participants Requiring Inotropic support use
timeFrame: During the procedure, 24-48 hours after the ablation procedure
measure: Number of Participants With Clinically Significant Pericardial Effusion
timeFrame: During the procedure, up to 24 hours after the ablation procedure
measure: Number of Participants With Acute kidney injury
timeFrame: During procedure, up to 24-48 hours after the ablation procedure
measure: Number of Participants Requiring intubation
timeFrame: During procedure, 24 hours after the ablation procedure
Secondary outcomes:
measure: Experimental procedural duration
timeFrame: During procedure
measure: noninvasive programmed stimulation (NIPS) sub-acutely after the procedure
timeFrame: 24-48 hours after the procedure.
measure: Mean and peak procedural lactate level
timeFrame: During procedure
measure: Cumulative procedural inotropic support use
timeFrame: During procedure, 24-48 hours after the ablation procedure
measure: Hospital stay length following the procedure
timeFrame: Periprocedural hospital stay length, up to 2 weeks
measure: Time to ventricular tachycardia (VT)
timeFrame: 1 year
measure: Antiarrhythmic Drugs requirement
timeFrame: Through study completion, an average of 1 year
measure: Left ventricular ejection fraction (LVEF)
timeFrame: 6 months after the study
measure: Left ventricular end-diastolic volume (EDV)
timeFrame: 6 months after the study
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of The University Of Pennsylvania
state: Pennsylvania
Study officials:
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