This is a multicenter, prospective, parallel, randomized controlled trial to test for non-inferiority with an ILAM-guided VT ablation compared to conventional voltage- based ablation. The study has two treatment arms: conventional voltage mapping and ablation (control arm). In the investigational arm, the ablation strategy is guided by ILAM to target deceleration zones, blinded to voltage mapping. In the control arm, ablation will be performed to extensively ablate all low voltage regions (\<1.5mV) during sinus rhythm, right ventricular (RV) pacing, or left ventricular (LV) pacing, with discretionary use of pacemapping and activation mapping. In both arms, mapping with be performed with a multielectrode catheter (HD Grid) and ablation will be performed using an irrigated tip catheter (FlexAbility SE or Tactiflex catheters). In the control armonly voltage mapping displays will be utilized (blinded to functional ILAM and fractionation). High density mapping with automated last deflection annotation (Ensite X) will be performed in all patients randomized to ILAM approach during either sinus rhythm or RV pacing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
360
an isochronal late activation mapping (ILAM) display with automated last deflection annotation (EnSite X™) will be used to identify regions of isochronal crowding around a line of conduction block for targeted ablation therapy using a standard irrigated tip catheter (Flexability SE \& Tactiflex catheters)
high-density voltage mapping will serve as the method to display the electroanatomic substrate for extensive and diffuse ablation within the low voltage area (\<1.5 mV).
Banner University Medical Center Phoenix
Phoenix, Arizona, United States
Inducibility for VT
Inducibility for VT after initial 25 minutes of ablation (minutes of radiofrequency)
Time frame: after initial 25 minutes of ablation (minutes of radiofrequency)
Recurrent VT
recurrent VT at 1 year
Time frame: 1 year post procedure
CV Hospitalization
Hospitalization due to Cardiovascular complications related to heart failure or arrhythmia at 1 year
Time frame: 1 year post procedure
Mortality
Mortality at 1 year
Time frame: 1 year post procedure
Procedure Related Safety
hematoma requiring transfusion, cardiac perforation, stroke, hemorrhage, pericardial effusion
Time frame: Duration of Hospitalization (up to 7 days)
Individual assessment of four endpoints comprising the primary endpoint.
Individual assessment of four individual endpoints comprising the primary endpoint.
Time frame: 1 year post procedure
Total radiofrequency time delivered and procedural time.
Time frame: Duration of Procedure
Reduction in VT burden
Time frame: 1 year post procedure
Quality of Life improvement
The overall quality of life will be assessed using the SF-36 instrument, which includes 36 items rated on a 4-point Likert scale. In all nine subscales, lower scores indicate poorer outcomes in various areas, including physical functioning, social limitations due to physical or mental health issues, challenges related to work or daily activities, and feelings of nervousness, depression, fatigue, exhaustion, and pain.
Time frame: 1 year post procedure
Procedural complications
tamponade, hematoma requiring transfusion, stroke, emergent surgery
Time frame: Duration of Hospitalization (up to 7 days)
Length of stay in hospital from index procedure
Time frame: Duration of Hospitalization (up to 7 days)
Rate of Acute Kidney Injury
Number of Participants with acute kidney injury, verified by creatinine checked the day after ablation.
Time frame: 1 day post procedure
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