RecruitingNot ApplicableNCT06138873

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

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


Sponsor

Rush University Medical Center

Enrollment

100 participants

Start Date

Oct 23, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria7

  • 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

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Interventions

PROCEDUREAblation-index guided ventricular tachycardia ablation

As described in arms descriptions

PROCEDUREVentricular tachycardia ablation with no AI-guidance

As described in arms descriptions


Locations(5)

Rush University Medical Center

Chicago, Illinois, United States

Mass General Brigham and Women's Hospital

Boston, Massachusetts, United States

Medical University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT06138873


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