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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT06138873
Status
Recruiting
Apply to this trial

Conditions

  • Ischemic Cardiomyopathy
  • Ventricular Tachycardia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ablation-index guided ventricular tachycardia ablation — PROCEDURE
    As described in arms descriptions
  • Ventricular tachycardia ablation with no AI-guidance — PROCEDURE
    As described in arms descriptions

Study Details

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.

Key Dates

Start date
Oct 23, 2024
Status verified
Sep 2025
Primary completion
Nov 23, 2026
Completion
Nov 23, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60614
Henry D Huang, MD
[email protected]
312-942-5020
Mass General Brigham and Women's HospitalBostonMassachusetts02115
Jorge E. Romero, MD
[email protected]
617-732-5241
Obadah Aloum
[email protected]
617-732-5241
Jorge Romero, MD (PRINCIPAL_INVESTIGATOR)
Medical University of MichiganAnn ArborMichigan48109
Jackson Liang, DO
[email protected]
888-287-1082
Jackson Liang, DO (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Konstantinos Siontis, MD
[email protected]
507-422-0549
Konstantinos Siontis, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Bishnu Dhakal, MD
[email protected]
843-876-2700
Chandler Schwede
[email protected]
843-792-5998
Bishnu Dhakal, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Rush University Medical Center· Chicago, ILMass General Brigham and Women's Hospital· Boston, MAMedical University of Michigan· Ann Arbor, MIMayo Clinic· Rochester, MNMedical University of South Carolina· Charleston, SC

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