Recruiting

Ablation-Index Guided

Sponsor:

Rush University Medical Center

Code:

NCT06138873

Conditions

Ventricular Tachycardia

Ischemic Cardiomyopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ablation-index guided ventricular tachycardia ablation

Ventricular tachycardia ablation with no AI-guidance

Study Details

Brief summary:

Over the last decade, radiofrequency catheter ablation (RFCA) has become an established treatment for ventricular arrhythmias (VA). Due to the challenging nature of visualizing lesion formation in real time and ensuring an effective transmural lesion, different surrogate measures of lesion quality have been used. The Ablation Index (AI) is a variable incorporating power delivery in its formula and combining it with CF and time in a weighted equation which aims at allowing for a more precise estimation of lesion depth and quality when ablating VAs. AI guidance has previously been shown to improve outcomes in atrial and ventricular ablation in patients with premature ventricular complexes (PVC). However research on outcomes following AI-guidance for VT ablation specifically in patients with structural disease and prior myocardial infarction remains sparse. The investigators aim at conducting the first randomized controlled trial testing for the superiority of an AI-guided approach regarding procedural duration.

Conditions

Ventricular Tachycardia

Ischemic Cardiomyopathy

Study ID

NCT06138873

Start date

Oct 23, 2024

Status verified date

Sep, 2025

Completion date

Nov 23, 2027

Anticipated

Primary completion date

Nov 23, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient ≥ 18 y.o.
  • Structural Heart Disease: Ischemic Cardiomyopathy
  • Sustained Scar-related Monomorphic Ventricular Tachycardia documented by ECG or CIED interrogation

Exclusion Criteria:

  • If clinical ventricular arrhythmia is predominantly PVCs, supraventricular tachycardia, or ventricular fibrillation
  • Myocardial infarction or cardiac surgery within 6 months
  • Severe mitral regurgitation
  • Stroke or TIA within 6 months
  • Prior VT substrate ablation in the previous 6 months
  • NYHA functional class IV
  • Non-ischemic VT substrate

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AI-guided ablation

Use of AI guidance to conduct the ablation

active comparator: non-AI guided ablation

Ablation without AI guidance, AI values masked to the operator.

Interventions

Ablation-index guided ventricular tachycardia ablation

As described in arms descriptions

Ventricular tachycardia ablation with no AI-guidance

As described in arms descriptions

Primary outcome measure

  • Percentage reduction in ablation time between the groups with/without AI guidance [ Time Frame: intra-procedural ]

Central Contacts and Locations

Central contacts

Alexander Mazur, MD

312-942-5020alexander_mazur@rush.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60614

Contacts

Henry D Huang, MD

312-942-5020henry_d_huang@rush.edu

More Information

Sponsor

Rush University Medical Center

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Keywords

  • ventricular
  • tachycardia
  • ablation index
  • ischemic cardiomyopathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2025-09-22.