AI-Guided Ablation for Ventricular Tachycardia in Heart Disease

(AIM-VT Trial)

Recruiting at 3 trial locations

Overseen By Henry Huang, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Rush University Medical Center

Disqualifiers: Recent MI, Cardiac surgery, Stroke, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Ventricular tachycardia ablation with AI-guidance?

Research shows that using advanced mapping technologies and techniques, such as non-contact mapping systems and epicardial mapping, can improve the success rates of ventricular tachycardia ablation by better identifying the areas in the heart that need treatment. ^{1 2 3 4 5}

Is ventricular tachycardia ablation generally safe for humans?

Research shows that ventricular tachycardia ablation is generally safe, with studies assessing safety in real-world clinical practice and identifying complication rates. However, specific safety data for AI-guided ablation is not detailed in the available research. ^{6 7 8 9 10}

How is AI-guided ablation for ventricular tachycardia different from other treatments?

AI-guided ablation for ventricular tachycardia is unique because it uses artificial intelligence to improve the precision of identifying the areas in the heart that need treatment, potentially increasing the success rate compared to traditional methods that rely on conventional mapping techniques. ^{1 11 12 13 14}

Research Team

Henry Huang, MD

Principal Investigator

[e-mail]

Eligibility Criteria

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.

I am 18 years old or older.

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.

Trial Timeline

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

Treatment Details

Interventions

• Ventricular tachycardia ablation (Procedure)
• Ventricular tachycardia ablation with no AI-guidance (Procedure)

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.

Participant Groups

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+

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

Findings from Research

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]

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]

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]

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 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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Mapping and ablation of ventricular tachycardia with the aid of a non-contact mapping system. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

[Update on ablation of ventricular tachyarrhythmias]. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Endo-epicardial vs endocardial-only catheter ablation of ventricular tachycardia: A meta-analysis. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a noncontact catheter for endocardial mapping of human ventricular tachycardia. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

VT ablation: New Developments and Approaches. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of ventricular tachycardia ablation in clinical practice: findings from 9699 hospital discharge records. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Mortality after catheter ablation of structural heart disease related ventricular tachycardia. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Risk score model for predicting complications in patients undergoing ventricular tachycardia ablation: insights from the National Inpatient Sample database. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Incidence and predictors of mortality following ablation of ventricular tachycardia in patients with an implantable cardioverter-defibrillator. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Ventricular Tachycardia Ablation in the Elderly: An International Ventricular Tachycardia Center Collaborative Group Analysis. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

Catheter ablation of ventricular tachycardia occurring late after myocardial infarction: a point-of-view. [2019]

12. China pubmed.ncbi.nlm.nih.gov

Transcoronary chemical ablation of ventricular tachycardia. [2013]

13. England pubmed.ncbi.nlm.nih.gov

Epicardial only mapping and ablation of ventricular tachycardia: a case series. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Clinical observations and outcome of ventricular tachycardia ablation in patients with left ventricular assist devices. [2012]