Ablation-Index Guided Scar-Mediated Ventricular Tachycardia Ablation in Patients With Ischemic Cardiomyopathy

NCT06138873 | Recruiting DMC

• 1 other identifier: AIM-VT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

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

Keywords

ventricular; tachycardia; ablation index; ischemic cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Percentage reduction in ablation time between the groups with/without AI guidance

  Percentage of reduction in ablation time in seconds, with ablation time defined as the total radiofrequency delivery time delivered during the VT ablation procedure. Total ablation time is automatically recorded by the Carto System Software and will be subsequently extracted as part of a raw unedited data file for unbiased endpoint evaluation.

  intra-procedural

Secondary Outcomes (3)

• Percentage of reduction in total procedural duration in seconds between the AI/not AI group

  intra-procedural

• Total intravenous fluids administered in milliliters (ml)

  intra-procedural

• Fluoroscopy duration in minutes

  intra-procedural

Other Outcomes (13)

• Acute procedural success (no inducible VT), partial success (only non-clinical VT induced), and inducibility not tested at end of procedure (in number, % and risk-difference)

  intra-procedural

• Average ablation time per lesion (in seconds and percentage difference)

  intra-procedural

• Number of RF lesions per patient (number, mean with standard deviation/median with interquartile range and percentage difference)

  intra-procedural

Study Arms (2)

AI-guided ablation

EXPERIMENTAL

Use of AI guidance to conduct the ablation

Procedure: Ablation-index guided ventricular tachycardia ablation

non-AI guided ablation

ACTIVE COMPARATOR

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

Procedure: Ventricular tachycardia ablation with no AI-guidance

Interventions

Ablation-index guided ventricular tachycardia ablation PROCEDURE

As described in arms descriptions

AI-guided ablation

Ventricular tachycardia ablation with no AI-guidance PROCEDURE

As described in arms descriptions

non-AI guided ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• University of Michigan: collaborator
• Medical University of South Carolina: collaborator
• Biosense Webster, Inc.: collaborator
• Mayo Clinic: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (5)

Rush University Medical Center

Chicago, Illinois, 60614, United States

RECRUITING

Mass General Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Medical University of Michigan

Ann Arbor, Michigan, 48109, United States

NOT YET RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

NOT YET RECRUITING

Related Publications (5)

• Proietti R, Lichelli L, Lellouche N, Dhanjal T. The challenge of optimising ablation lesions in catheter ablation of ventricular tachycardia. J Arrhythm. 2020 Dec 28;37(1):140-147. doi: 10.1002/joa3.12489. eCollection 2021 Feb.

  PMID: 33664896 BACKGROUND

• Larsen T, Du-Fay-de-Lavallaz JM, Winterfield JR, Ravi V, Rhodes P, Wasserlauf J, Trohman RG, Sharma PS, Huang HD. Comparison of ablation index versus time-guided radiofrequency energy dosing using normal and half-normal saline irrigation in a porcine left ventricular model. J Cardiovasc Electrophysiol. 2022 Apr;33(4):698-712. doi: 10.1111/jce.15379. Epub 2022 Jan 30.

  PMID: 35048448 BACKGROUND

• Hussein A, Das M, Riva S, Morgan M, Ronayne C, Sahni A, Shaw M, Todd D, Hall M, Modi S, Natale A, Dello Russo A, Snowdon R, Gupta D. Use of Ablation Index-Guided Ablation Results in High Rates of Durable Pulmonary Vein Isolation and Freedom From Arrhythmia in Persistent Atrial Fibrillation Patients: The PRAISE Study Results. Circ Arrhythm Electrophysiol. 2018 Sep;11(9):e006576. doi: 10.1161/CIRCEP.118.006576.

  PMID: 30354288 BACKGROUND

• Gasperetti A, Sicuso R, Dello Russo A, Zucchelli G, Saguner AM, Notarstefano P, Soldati E, Bongiorni MG, Della Rocca DG, Mohanty S, Carbucicchio C, Duru F, Di Biase L, Natale A, Tondo C, Casella M. Prospective use of ablation index for the ablation of right ventricle outflow tract premature ventricular contractions: a proof of concept study. Europace. 2021 Jan 27;23(1):91-98. doi: 10.1093/europace/euaa228.

  PMID: 33063099 BACKGROUND

• Bates AP, Paisey J, Yue A, Banks P, Roberts PR, Ullah W. Radiofrequency Ablation of the Diseased Human Left Ventricle: Biophysical and Electrogram-Based Analysis. JACC Clin Electrophysiol. 2023 Mar;9(3):330-340. doi: 10.1016/j.jacep.2022.10.001. Epub 2022 Oct 10.

  PMID: 36371330 BACKGROUND

MeSH Terms

Conditions

Tachycardia, Ventricular; Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Mazur, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Mazur, MD

CONTACT

312-942-5020; alexander_mazur@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 18, 2023
• Study Start: October 23, 2024
• Primary Completion (Estimated): November 23, 2026
• Study Completion (Estimated): November 23, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)