Ablation-Index Guided Scar-Mediated Ventricular Tachycardia Ablation in Patients With Ischemic Cardiomyopathy (AIM-VT) - a Prospective Single-Blinded, Multicenter Randomized Controlled Trial

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient ≥ 18 y.o.

• Structural Heart Disease: Ischemic Cardiomyopathy

• Sustained Scar-related Monomorphic Ventricular Tachycardia documented by ECG or CIED interrogation

Locations
United States
Illinois
Rush University Medical Center
RECRUITING
Chicago
Massachusetts
Mass General Brigham and Women's Hospital
NOT_YET_RECRUITING
Boston
Michigan
Medical University of Michigan
NOT_YET_RECRUITING
Ann Arbor
Minnesota
Mayo Clinic
NOT_YET_RECRUITING
Rochester
South Carolina
Medical University of South Carolina
NOT_YET_RECRUITING
Charleston
Contact Information
Primary
Alexander Mazur, MD
alexander_mazur@rush.edu
312-942-5020
Time Frame
Start Date: 2024-10-23
Estimated Completion Date: 2027-11-23
Participants
Target number of participants: 100
Treatments
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.
Sponsors
Collaborators: Mayo Clinic, Medical University of South Carolina, Brigham and Women's Hospital, University of Michigan, Biosense Webster, Inc.
Leads: Rush University Medical Center

This content was sourced from clinicaltrials.gov