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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

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
NameTimeMethod
Inducibility for VTafter initial 25 minutes of ablation (minutes of radiofrequency)

Inducibility for VT after initial 25 minutes of ablation (minutes of radiofrequency)

Recurrent VT1 year post procedure

recurrent VT at 1 year

CV Hospitalization1 year post procedure

Hospitalization due to Cardiovascular complications related to heart failure or arrhythmia at 1 year

Mortality1 year post procedure

Mortality at 1 year

Procedure Related SafetyDuration of Hospitalization (up to 7 days)

hematoma requiring transfusion, cardiac perforation, stroke, hemorrhage, pericardial effusion

Secondary Outcome Measures
NameTimeMethod
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 burden1 year post procedure
Quality of Life improvement1 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 complicationsDuration of Hospitalization (up to 7 days)

tamponade, hematoma requiring transfusion, stroke, emergent surgery

Length of stay in hospital from index procedureDuration of Hospitalization (up to 7 days)
Rate of Acute Kidney Injury1 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

Banner University Medical Center Phoenix
🇺🇸Phoenix, Arizona, United States
Mason Burchfield
Contact
6022557551
mlburchfi@arizona.edu
Elena Young
Contact
602-255-7553
elenay@arizona.edu
Peter Weiss, MD
Contact

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