Functional ElectroAnatomiC Isochronal Late Activation Mapping for Empiric VT Ablation Trial

Conditions

• Recurrent Ventricular Tachycardia
• Sustained Monomorphic VT (MMVT)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Isochronal Late Activation Mapping (ILAM) — DEVICE
  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 — DEVICE
  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).

Study Details

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.

Key Dates

Start date

Apr 15, 2025

Status verified

Apr 2025

Primary completion

Apr 30, 2028

Completion

Apr 30, 2029

Study Design

Enrollment

360 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: High Density Voltage Mapping
  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)
• Experimental: Isochronal Late Activation Mapping (ILAM)
  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).

Primary Outcome Measure

Inducibility for VT [ Time Frame: after initial 25 minutes of ablation (minutes of radiofrequency) ]

Central Contacts

• Priyanka Sharma
  602-521-3090
  [email protected]
• Dalise Shatz
  602-839-4540
  [email protected]

Locations (1)

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