RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-23
Study Completion:2027-11-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06138873

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient ≥ 18 y.o.
  2. * Structural Heart Disease: Ischemic Cardiomyopathy
  3. * Sustained Scar-related Monomorphic Ventricular Tachycardia documented by ECG or CIED interrogation
  1. * If clinical ventricular arrhythmia is predominantly PVCs, supraventricular tachycardia, or ventricular fibrillation
  2. * Myocardial infarction or cardiac surgery within 6 months
  3. * Severe mitral regurgitation
  4. * Stroke or TIA within 6 months
  5. * Prior VT substrate ablation in the previous 6 months
  6. * NYHA functional class IV
  7. * Non-ischemic VT substrate

Contacts and Locations

Study Contact

Henry Huang, MD
CONTACT
942-5020
Henry_D_Huang@rush.edu

Principal Investigator

Henry Huang, MD
PRINCIPAL_INVESTIGATOR
Henry_D_Huang@rush.edu

Study Locations (Sites)

Rush University Medical Center
Chicago, Illinois, 60614
United States
Medical University of Michigan
Ann Arbor, Michigan, 48109
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Rush University Medical Center

  • Henry Huang, MD, PRINCIPAL_INVESTIGATOR, Henry_D_Huang@rush.edu

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-23
Study Completion Date2027-11-23

Study Record Updates

Study Start Date2024-10-23
Study Completion Date2027-11-23

Terms related to this study

Keywords Provided by Researchers

  • ventricular
  • tachycardia
  • ablation index
  • ischemic cardiomyopathy

Additional Relevant MeSH Terms

  • Ventricular Tachycardia
  • Ischemic Cardiomyopathy