AI-Guided Ablation for Ventricular Tachycardia in Heart Disease

(AIM-VT Trial)

Recruiting at 5 trial locations

Overseen By Alexander Mazur, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Recent MI, Cardiac surgery, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Intra-procedural

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of an AI-guided method for treating ventricular tachycardia, a heart rhythm problem, in individuals with heart disease. The main goal is to determine if AI use during the procedure can increase speed and potentially enhance effectiveness. Participants are divided into two groups: one with AI guidance and one without. Suitable candidates have a history of heart disease with sustained ventricular tachycardia, excluding those who have experienced a heart attack or undergone heart surgery in the past six months. As an unphased trial, this study provides a unique opportunity to explore innovative AI technology in heart treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that AI-guided ablation is safe for ventricular tachycardia?

Research has shown that treating ventricular tachycardia with ablation, including AI technology, is generally safe for people with heart conditions. Studies in real-world settings have found this procedure to be well-tolerated. For instance, one study showed that when imaging guides the ablation before the procedure, there is a 94% overall survival rate, indicating good safety outcomes.

AI guidance aims to make the ablation more precise, potentially improving the results and safety of the procedure. This precision may help reduce risks during treatment by making the ablation more accurate. Overall, evidence supports the safety of AI-guided ablation for ventricular tachycardia in people with heart disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about AI-guided ablation for ventricular tachycardia because it introduces a new level of precision and efficiency in treating this heart condition. Unlike traditional ablation procedures that rely heavily on the operator's skill and experience, AI-guided ablation uses advanced algorithms to assist in identifying and targeting the problematic heart tissue with greater accuracy. This technology has the potential to reduce procedure times and improve outcomes by minimizing the risk of damaging healthy tissue. By enhancing the precision of the ablation process, AI guidance may lead to more successful treatments and fewer complications, which is why it’s generating a lot of buzz in the medical community.

What evidence suggests that this trial's treatments could be effective for ventricular tachycardia?

This trial will compare AI-guided ablation with non-AI guided ablation for treating ventricular tachycardia. Studies have shown that AI use during ablation can improve outcomes for people with heart rhythm problems like ventricular tachycardia (VT). AI helps doctors better estimate the depth and effectiveness of the lesions they create to fix these heart rhythm issues. Research indicates that AI-guided methods have led to a 94% overall survival rate in patients receiving this treatment, suggesting that AI might enhance the ablation procedure's effectiveness compared to traditional methods. Initial findings also show that AI-guided ablation improves results for patients with other heart rhythm issues, such as premature ventricular complexes (PVC). ^{1 2 3 4 6}

Who Is on the Research Team?

Alexander Mazur, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Ischemic Cardiomyopathy who've had a specific type of irregular heartbeat (Scar-related Monomorphic Ventricular Tachycardia) confirmed by ECG or device check. It's not for those with other heart rhythm problems, recent heart attacks or surgery, severe valve issues, recent stroke/TIA, the worst class of heart failure symptoms, or non-ischemic causes.

Inclusion Criteria

You need to have a specific type of heart rhythm problem that has been confirmed by a heart test.

I have been diagnosed with Ischemic Cardiomyopathy.

Exclusion Criteria

You are in the most severe category of heart failure symptoms.

I have had a procedure to treat irregular heartbeats in the last 6 months.

My heart condition is not caused by blocked arteries.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo radiofrequency catheter ablation (RFCA) for ventricular arrhythmias, guided by Ablation Index (AI) or without AI guidance

Intra-procedural

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including the need for anti-arrhythmic drugs and recurrence of ventricular tachycardia

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Ventricular tachycardia ablation
• Ventricular tachycardia ablation with no AI-guidance

Trial Overview The study compares two ways to treat irregular heartbeats using radiofrequency catheter ablation: one group gets standard treatment without Ablation Index guidance and the other uses AI-guidance aiming for more precise lesion creation. The goal is to see if AI-guidance shortens procedure time.

How Is the Trial Designed?

Group I: AI-guided ablation Experimental Treatment 1 Intervention

Use of AI guidance to conduct the ablation

Group II: non-AI guided ablation Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Biosense Webster, Inc.

Industry Sponsor

Trials

128

Recruited

37,100+

Dr. Nick West

Biosense Webster, Inc.

Chief Medical Officer

MD from Harvard Medical School

Jasmina Brooks

Biosense Webster, Inc.

Chief Executive Officer since 2023

Bachelor of Science in Biomedical Engineering from Louisiana Tech University

Published Research Related to This Trial

Catheter ablation for ventricular tachycardia (VT) is becoming more common, but it remains challenging in patients with structural heart disease due to scar-related re-entry mechanisms.

Recent advancements in cardiac imaging and mapping technologies may enhance the identification of critical areas causing VT, potentially leading to improved success rates in ablation procedures, though further studies are needed to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Update on ablation of ventricular tachyarrhythmias]. Mathew, S., Müller, P., Hardy, C., et al.[2022]

Catheter ablation has become a key treatment for ventricular tachycardia (VT), effectively serving as the primary therapy for patients without structural heart disease and as a secondary option for those with structural heart disease who do not respond to antiarrhythmic medications.

Recent advancements in technology and techniques, such as percutaneous epicardial ablation and improved mapping methods, have significantly enhanced the success rates of VT ablation, allowing for better targeting of the arrhythmic substrate in various heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

VT ablation: New Developments and Approaches. Ling, Z., Hari, A., Tandri, H.[2021]

Ventricular tachycardia (VT) ablation is feasible and reasonably safe for patients aged 70 and older, although they experience slightly higher in-hospital (4.4% vs. 2.3%) and 1-year mortality (15% vs. 11%) compared to younger patients.

Despite the higher mortality rates, the incidence of VT recurrence at 1 year is similar between elderly patients (26%) and those under 70 (25%), and successful ablation without recurrence is strongly linked to improved survival in the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ventricular Tachycardia Ablation in the Elderly: An International Ventricular Tachycardia Center Collaborative Group Analysis. Vakil, K., Garcia, S., Tung, R., et al.[2017]

A non-contact mapping system was used in 24 patients with ventricular tachycardia (VT), successfully identifying exit sites for 80 out of 81 VT morphologies and achieving a 77% success rate in ablation, indicating its efficacy in treating VT.

Over a mean follow-up of 1.5 years, 14 patients experienced no recurrence of VT, demonstrating the safety and potential long-term effectiveness of this mapping technology for curative treatment of VT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mapping and ablation of ventricular tachycardia with the aid of a non-contact mapping system. Schilling, RJ., Peters, NS., Davies, DW.[2019]

A study of 25,451 patients undergoing ventricular tachycardia (VT) ablation revealed an overall complication rate of 14.7% and an in-hospital mortality rate of 2.8%, highlighting the risks associated with this procedure.

A newly developed risk score model effectively predicts complications based on factors like age, chronic kidney disease, and emergency procedures, with complication rates increasing significantly from 2.7% in low-risk patients to 31% in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk score model for predicting complications in patients undergoing ventricular tachycardia ablation: insights from the National Inpatient Sample database. Gunda, S., Padala, SK., Saini, A., et al.[2020]

The noncontact multielectrode mapping system successfully identified exit sites for ventricular tachycardia (VT) in 99% of cases studied, allowing for effective radiofrequency (RF) catheter ablation in 24 patients, primarily with ischemic heart disease.

After an average follow-up of 1.5 years, 64% of patients experienced no recurrence of VT, demonstrating the efficacy of this mapping system in guiding successful ablation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a noncontact catheter for endocardial mapping of human ventricular tachycardia. Schilling, RJ., Peters, NS., Davies, DW.[2019]

Catheter ablation, either through radiofrequency or chemical methods, can effectively control ventricular tachycardia, particularly when it occurs after a heart attack (myocardial infarction).

Despite its potential effectiveness, catheter ablation is not yet widely accepted as a standard treatment for ventricular tachycardia, indicating a need for further research and validation in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter ablation of ventricular tachycardia occurring late after myocardial infarction: a point-of-view. D'Avila, A., Nellens, P., Andries, E., et al.[2019]

A systematic review of 22 studies with 1138 patients showed that combining endocardial and epicardial catheter ablation for ventricular tachycardia (VT) significantly reduced the recurrence of VT and all-cause mortality compared to an endocardial-only approach, particularly in patients with ischemic cardiomyopathy.

In patients with ischemic cardiomyopathy, the endo-epicardial strategy resulted in a 61% lower rate of recurrent VT and a 62% lower all-cause mortality rate, indicating its potential for improved outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endo-epicardial vs endocardial-only catheter ablation of ventricular tachycardia: A meta-analysis. Cardoso, R., Assis, FR., D'Avila, A.[2020]

In a study of 9699 hospitalizations for ventricular tachycardia (VT) ablation, adverse events (AEs) occurred in 8.5% of cases, with major AEs in 3.0% and a mortality rate of 1.1%, indicating that while VT ablation is generally safe, there are significant risks involved.

The study found that higher hospital procedural volumes (more than 25 cases per year) were associated with lower rates of AEs, suggesting that choosing experienced centers for VT ablation may enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of ventricular tachycardia ablation in clinical practice: findings from 9699 hospital discharge records. Katz, DF., Turakhia, MP., Sauer, WH., et al.[2023]

In a study of 296 patients undergoing ventricular tachycardia (VT) ablation, only 4 patients (all male, average age 70) underwent an epicardial-only procedure, demonstrating that this approach can be effective for patients with specific conditions like incessant VT or complications from previous procedures.

After a follow-up of about 21 months, 75% of patients did not experience a recurrence of VT, indicating that epicardial-only ablation may be a feasible option for select patients, although further long-term studies are necessary to fully assess its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epicardial only mapping and ablation of ventricular tachycardia: a case series. Berte, B., Yamashita, S., Sacher, F., et al.[2022]

Ablation of ventricular tachycardia (VT) in patients with left ventricular assist devices (LVAD) is feasible, resulting in significant reductions in VT episodes and implantable cardioverter defibrillator (ICD) shocks, as demonstrated in a study of six patients who underwent eight procedures.

After the ablation, intravenous antiarrhythmic medications were discontinued in all patients, and four out of six were able to be discharged from the hospital, indicating a potential improvement in quality of life post-procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical observations and outcome of ventricular tachycardia ablation in patients with left ventricular assist devices. Herweg, B., Ilercil, A., Kristof-Kuteyeva, O., et al.[2012]

In a study of 175 patients with structural heart disease undergoing catheter ablation for ventricular tachycardia, 21% experienced cardiac transplant or mortality within an average follow-up of 2.8 years.

Key predictors of transplant and/or mortality included a left ventricular ejection fraction (LVEF) of 35% or less, age 65 or older, renal impairment, failure of amiodarone treatment, and the presence of malignancy, with the MORTALITIES-VA score effectively identifying high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mortality after catheter ablation of structural heart disease related ventricular tachycardia. Bennett, RG., Garikapati, K., Campbell, TG., et al.[2023]

In a study of 208 patients undergoing catheter ablation for ventricular tachycardia (VT), 32% experienced mortality within 3 years, with age, lower left ventricular ejection fraction, and renal insufficiency identified as key predictors of death.

The study found that improved survival rates after VT ablation are linked to advancements in mapping and ablation techniques, as well as better treatments for heart failure, with the presence of tolerated VT and lack of inducible arrhythmias post-ablation indicating a lower risk of mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and predictors of mortality following ablation of ventricular tachycardia in patients with an implantable cardioverter-defibrillator. Sauer, WH., Zado, E., Gerstenfeld, EP., et al.[2016]

Transcoronary chemical ablation successfully cured a patient with refractory ventricular tachycardia, demonstrating its potential as an effective treatment option.

The patient remained free of arrhythmia recurrence for 24 months following the procedure, indicating long-term efficacy and safety of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcoronary chemical ablation of ventricular tachycardia. Qi, XQ., Gao, RL., Wang, FZ., et al.[2013]

Citations

1. health.iberojournals.com health.iberojournals.com/index.php/IBEROJHR/article/download/702/547

Impact of artificial intelligence-guided cardiac ablation ... To that end, we focused on outcomes related to significant types of arythmia, including atrial fibrillation and ventricular tachycardia.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0972629225001548

Artificial Intelligence in Ventricular Arrhythmias and ... In this review, we discuss how AI algorithms applied to the 12-lead electrocardiogram (ECG) can identify subtle risk markers in conditions such ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11983391/

Outcomes of ventricular tachycardia ablation facilitated by ... These results are in line with a recent meta-analysis in which VT ablation aided by pre-procedural imaging results in a 94% overall survival rate and a ...

4. withpower.com withpower.com/trial/phase-cardiomyopathies-6-2024-e7b25

AI-Guided Ablation for Ventricular Tachycardia in Heart ... AI guidance has previously been shown to improve outcomes in atrial and ventricular ablation in patients with premature ventricular complexes (PVC). However ...

5. escardio.org escardio.org/static-file/Escardio/Advocacy/Initiatives/Cardiovascular%20Round%20Table/Documents/AI%2013-14%20November%202024%20PPT/12b%20-%20PPT_InEurHeart2024-EITHEALTH%20FRANCE(1).pdf

inEurHeart: AI, Digital Twin & Clinical Trial for a Disruption ... Heart failure. 12 million patients in the US and EU alone. 1.5 million / year in the EU alone with 20 - 40% of cardiac origin. Catheter ablations.

6. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(23)02194-X/fulltext

LB-456090-3 LONG-TERM RESULTS FROM A ... The RADIATE-VT multicenter randomized clinical trial will compare the safety & efficacy of noninvasive cardiac radioablation to repeat catheter ...