The STandard versus ImAging SuBstrate Aided Ablation in Severe Left VEntricular Dysfunction VT
Brief description of study
PURPOSE:
The overall purpose of the study is to assess the procedural safety profile and clinical efficacy outcomes of an imaging substrate-aided ventricular tachycardia (VT) ablation strategy that avoids general anesthesia, limits inductions, and reduces time devoted to substrate mapping in heart failure patients with severe left ventricular dysfunction.
Primary objective:
To determine whether imaging substrate-aided ventricular tachycardia ablation strategy improves procedural safety and hemodynamic profiles, reduces the number of acute major adverse cardiovascular events (MACE), and need for mechanical and inotropic support beyond 24 hours compared to standard approach. Herein, we will compare the safety and clinical efficacy of this imaging substrate-aided strategy to a control arm.
Secondary objective:
To determine whether an imaging-aided ventricular tachycardia ablation strategy improves procedural duration, cumulative periprocedural inotropic support need, mean and peak procedural lactate level, organ perfusion, hospital length of stay, left ventricular end-systolic function and volume, and end-diastolic volume at 6 months and 1 year follow-up, anti-arrhythmic requirement following the procedure, has comparable freedom from VT at noninvasive programmed stimulation (NIPS) sub-acutely after the procedure and at long-term follow-up (6 and 12 month follow-up). o Vital signs and hemodynamic parameters
o Comorbid conditions
o Laboratory data to be captured peri-procedurally.
Creatinine
eGFR
Sodium
Potassium
BUN
Hemoglobin
Total Bilirubin
AST/ALT
Albumin
Lactate (mean and peak lactate during ablation procedure)
o Use of inotropic support beyond 24 hours following the procedure
o Use of mechanical support with intra-aortic balloon pump, Impella, LVAD or transplant periprocedurally
o Incidence rate of VT recurrence following the procedure, characterization and rate of VT following the procedure
o Incidence rate of death, cardiovascular death, stroke, transient ischemic attack, myocardial infarction post procedure
o Use of antiarrhythmic post procedure
o Need for intubation beyond 24 hrs
o Need for heart transplantation within 30 days of procedure o Procedure details including:
Number of ventricular tachycardia inductions
Number of distinct VT morphologies and/or cycle lengths observed
Number of shocks
Type of mapping catheter
Number of intracardiac points sampled
Type of ablation catheter
Number of RF lesions delivered
RF duration (total)
VT inducibility at case end (yes/no/not checked)
Procedure duration (the time from the insertion of catheters through the femoral vein to the time of their withdrawal)
o Echocardiographic parameters including change in ejection fraction, end-diastolic pressure, valvular disease, and clinically significant pericardial effusion
o Hospital stay length following the procedure
o Number of heart failure hospitalization in the previous 6 months prior to referral for VT ablation
Eligibility of study
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Medical Research
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Age: - 99 Years
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Gender: All
Updated on
08 Feb 2023.
Study ID: 851281
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