Functional ElectroAnatomiC Isochronal Late Activation Mapping for Empiric VT Ablation Trial

Not Applicable

Not yet recruiting

• Conditions: Sustained Monomorphic VT (MMVT); Recurrent Ventricular Tachycardia

• Registration Number: NCT06931821
• Lead Sponsor: University of Arizona

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-09
• Last Update Submitted: 2025-04-09
• Study Start: 2025-04-15
• Study First Posted: 2025-04-17
• Last Update Posted: 2025-04-17
• Primary Completion: 2028-04-30
• Study Completion: 2029-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Inducibility for VT	after initial 25 minutes of ablation (minutes of radiofrequency)	Inducibility for VT after initial 25 minutes of ablation (minutes of radiofrequency)
Recurrent VT	1 year post procedure	recurrent VT at 1 year
CV Hospitalization	1 year post procedure	Hospitalization due to Cardiovascular complications related to heart failure or arrhythmia at 1 year
Mortality	1 year post procedure	Mortality at 1 year
Procedure Related Safety	Duration of Hospitalization (up to 7 days)	hematoma requiring transfusion, cardiac perforation, stroke, hemorrhage, pericardial effusion

Secondary Outcome Measures

Name	Time	Method
Individual assessment of four endpoints comprising the primary endpoint.	1 year post procedure	Individual assessment of four individual endpoints comprising the primary endpoint.
Total radiofrequency time delivered and procedural time.	Duration of Procedure
Reduction in VT burden	1 year post procedure
Quality of Life improvement	1 year post procedure	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.
Procedural complications	Duration of Hospitalization (up to 7 days)	tamponade, hematoma requiring transfusion, stroke, emergent surgery
Length of stay in hospital from index procedure	Duration of Hospitalization (up to 7 days)
Rate of Acute Kidney Injury	1 day post procedure	Number of Participants with acute kidney injury, verified by creatinine checked the day after ablation.

Trial Locations

Locations (1)

Banner University Medical Center Phoenix; 🇺🇸 Phoenix, Arizona, United States