Venous Ethanol for Ventricular Tachycardia

(VELVET Trial)

Overseen By Iris Melissa Alanis

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The Methodist Hospital Research Institute

Disqualifiers: Renal impairment, Heart failure, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: During procedure

156 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves treatments for ventricular tachycardia, it's possible that adjustments to your medications might be needed. Please consult with the trial coordinators for specific guidance.

What data supports the effectiveness of this treatment for ventricular tachycardia?

Research shows that venous ethanol ablation can be effective for treating ventricular arrhythmias, especially when conventional methods like radiofrequency ablation fail. Ethanol infusion targets deep-seated arrhythmic areas that are hard to reach with other techniques, offering an alternative for patients with difficult-to-treat ventricular tachycardia. ^{1 2 3 4 5}

Is venous ethanol ablation generally safe for humans?

Venous ethanol ablation can be effective for treating certain heart rhythm problems, but it may cause complications like heart block (a problem with the heart's electrical system) and inflammation of the heart lining. While it shows promise, there are safety concerns that need to be considered. ^{3 4 5 6 7}

How is venous ethanol for ventricular tachycardia different from other treatments?

Venous ethanol ablation is unique because it targets deep-seated areas in the heart that are not reachable by standard catheter ablation methods, using ethanol (a type of alcohol) to destroy problematic heart tissue. This approach is particularly useful when conventional treatments like radiofrequency ablation fail, offering an alternative route through the veins rather than the arteries, which can reduce certain risks. ^{1 2 4 5 7}

What is the purpose of this trial?

Comparative effectiveness randomized clinical trial, comparing endocardial radiofrequency ablation alone vs radiofrequency ablation combined with venous ethanol in patients with ischemic ventricular tachycardia -Venous Ethanol for Left Ventricular Ischemic Ventricular Tachycardia -VELVET clinical trial

Research Team

Miguel Valderrabano, MD

Principal Investigator

The Methodist Hospital Research Institute

Eligibility Criteria

This trial is for men and women aged 18-85 with ischemic cardiomyopathy, evidenced by a past heart attack or heart muscle issues. They must have had multiple rapid heartbeat episodes treated with pacing or drugs, an ICD shock, or documented ventricular tachycardia. Candidates should be eligible for radiofrequency ablation therapy and willing to follow the study's procedures.

Inclusion Criteria

You are able and willing to meet all the before, after, and check-up requirements.

I have heart muscle damage from a past heart attack.

I've had multiple episodes of a specific heart rhythm problem in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endocardial radiofrequency ablation alone or combined with venous ethanol ablation

During procedure

1 visit (in-person)

Follow-up

Participants are monitored for VT recurrence, procedural complications, and other outcomes

12 months

Extension/Long-term follow-up

Participants may continue to be monitored for long-term outcomes such as cardiac transplant or left ventricular assist device implantation

Beyond 12 months

Treatment Details

Interventions

• Catheter ablation
• Venous ethanol

Trial Overview The VELVET clinical trial is testing two treatments for severe rapid heartbeat due to heart muscle damage: one group receives standard catheter ablation while the other gets additional venous ethanol treatment. Participants are randomly assigned to either method.

Participant Groups

Group I: Venous ethanol Experimental Treatment 2 Interventions

Endocardial radiofrequency ablation of ventricular tachycardia combined with venous ethanol ablation of the tachycardia substrate

Group II: Control Active Control 1 Intervention

Endocardial radiofrequency ablation of ventricular tachycardia

Catheter ablation is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Catheter ablation for:

• Atrial fibrillation
• Supraventricular tachycardia
• Ventricular tachycardia

Approved in United States as Catheter ablation for:

• Atrial fibrillation
• Supraventricular tachycardia
• Ventricular tachycardia

Approved in Canada as Catheter ablation for:

• Atrial fibrillation
• Supraventricular tachycardia
• Ventricular tachycardia

Approved in Japan as Catheter ablation for:

• Atrial fibrillation
• Supraventricular tachycardia
• Ventricular tachycardia

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Findings from Research

Catheter-based radiofrequency ablation is a proven treatment for ventricular tachycardia (VT), but many patients experience recurrences, especially those with hard-to-reach arrhythmia sources.

Unconventional techniques like transarterial and retrograde coronary venous ethanol ablation show promise in treating RF-refractory VT, suggesting alternative options for patients with challenging arrhythmia substrates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol Ablation for Ventricular Tachycardia. Lador, A., Da-Wariboko, A., Tavares, L., et al.[2021]

Ethanol infusion is a valuable alternative treatment for cardiac arrhythmias, particularly in cases of ventricular tachycardia where conventional radiofrequency ablation (RFA) fails, allowing targeting of deep-seated arrhythmic foci.

Recent studies are investigating the use of ethanol injection through cardiac venous systems, such as the vein of Marshall, to reduce complications and enhance the effectiveness of catheter ablation procedures for conditions like atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethanol for the treatment of cardiac arrhythmias. Schurmann, P., Peñalver, J., Valderrábano, M.[2018]

Ethanol ablation (EA) shows a 72.4% acute success rate in treating ventricular arrhythmias (VAs) in a study of 174 patients, with a 1-year freedom from VA recurrence in 60%-75% of cases, indicating its potential as an effective treatment for refractory VAs.

However, the procedure carries a 14.1% complication rate, with significant risks such as pericardial complications and complete atrioventricular block, emphasizing the need for careful patient selection and further research to improve safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethanol ablation for ventricular arrhythmias: A systematic review and meta-analysis. Creta, A., Earley, MJ., Schilling, RJ., et al.[2022]

Venous ethanol ablation (VEA) effectively creates intramural scars in the left ventricular summit (LVS) without compromising ventricular function or septal integrity, as shown in a study of 59 patients.

The study utilized intracardiac echocardiography (ICE) and cardiac magnetic resonance (CMR) imaging to track the ablation process and demonstrated that the volume of ablated tissue correlated with the amount of ethanol used, indicating a controlled and measurable approach to the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute and Long-Term Scar Characterization of Venous Ethanol Ablation in the Left Ventricular Summit. Fuentes Rojas, SC., Malahfji, M., Tavares, L., et al.[2023]

In a study involving 26 anesthetized pigs, higher concentrations of ethanol (≥50%) used in intracoronary ablation were found to create larger myocardial lesions, indicating their effectiveness in the procedure.

However, these higher ethanol concentrations also led to greater impairment of left ventricular function and an increased risk of arrhythmias, suggesting a trade-off between efficacy and safety in arrhythmia therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracoronary ethanol ablation in swine: effects of ethanol concentration on lesion formation and response to programmed ventricular stimulation. Haines, DE., Whayne, JG., DiMarco, JP.[2019]

Intracoronary ethanol ablation was found to be moderately effective in terminating paroxysmal ventricular tachycardia in patients with a history of myocardial infarction, with successful termination observed in 10 out of 21 patients during the study.

While the technique showed promise for long-term control of ventricular tachycardia, it also carried risks, including complications such as complete atrioventricular block in four patients and pericarditis in one patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracoronary ethanol ablation for the treatment of recurrent sustained ventricular tachycardia. Kay, GN., Epstein, AE., Bubien, RS., et al.[2019]

In a study of 334 patients undergoing ventricular tachycardia (VT) ablation, retrograde coronary venous ethanol ablation was successfully performed in 7 patients, particularly after failed attempts at radiofrequency ablation (RFA), demonstrating its feasibility as a backup treatment.

This method was found to be safe, with no complications directly from the ethanol ablation, although one patient experienced a pericardial effusion due to instrumentation; follow-up showed that while VT recurred in 4 out of 7 patients, 3 were successfully reablated with RFA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrograde Coronary Venous Ethanol Infusion for Ablation of Refractory Ventricular Tachycardia. Kreidieh, B., Rodríguez-Mañero, M., Schurmann, P., et al.[2018]

References

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

Alcohol Ablation for Ventricular Tachycardia. [2021]

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

Ethanol for the treatment of cardiac arrhythmias. [2018]

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

Ethanol ablation for ventricular arrhythmias: A systematic review and meta-analysis. [2022]

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

Acute and Long-Term Scar Characterization of Venous Ethanol Ablation in the Left Ventricular Summit. [2023]

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

Intracoronary ethanol ablation in swine: effects of ethanol concentration on lesion formation and response to programmed ventricular stimulation. [2019]

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

Intracoronary ethanol ablation for the treatment of recurrent sustained ventricular tachycardia. [2019]

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

Retrograde Coronary Venous Ethanol Infusion for Ablation of Refractory Ventricular Tachycardia. [2018]