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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods for treating ischemic ventricular tachycardia, a heart condition causing fast and irregular heartbeats. It compares the standard treatment, radiofrequency ablation (which uses heat to destroy abnormal heart tissue), with a new approach that adds venous ethanol (a type of alcohol) to target problem areas more precisely. Individuals who have had a heart attack and experienced several irregular heartbeat episodes in the past six months might be suitable for this trial. Participants should already have a heart device implanted and be open to trying a new treatment strategy.

As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in heart care.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that venous ethanol can safely treat ventricular tachycardia, a type of fast heart rhythm. In some studies, venous ethanol proved to be a safe option, especially when other treatments were ineffective. For example, one study found that venous ethanol reduced the frequency of these rapid heart rhythms.

Another study examined venous ethanol as a backup method when traditional treatments failed. It concluded that venous ethanol was not only feasible but also safe for patients in these situations. This suggests that the treatment is well-tolerated and could be a reliable option for some individuals.

While these findings are promising, it's important to note that this information comes from early-stage studies. More research is needed to fully understand the safety and effectiveness of venous ethanol for treating ventricular tachycardia. However, current data suggests that venous ethanol is generally safe for use in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using venous ethanol for treating ventricular tachycardia because it offers a novel approach compared to traditional methods. While standard treatments like catheter ablation focus on delivering radiofrequency energy to eliminate problematic heart tissue, venous ethanol ablation targets the tachycardia substrate directly. This unique mechanism could potentially improve the effectiveness of treatment by more precisely disrupting the electrical signals causing the arrhythmia. By combining the precision of catheter ablation with the targeted action of venous ethanol, this approach might lead to better outcomes for patients who have not responded well to existing therapies.

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

Research has shown that venous ethanol, one of the treatments in this trial, can effectively treat ventricular tachycardia, a fast heart rhythm problem. Studies have found that venous ethanol can reduce the occurrence of this condition by up to 96%. In another study, ethanol alone succeeded in 76% of patients with difficult-to-treat cases. Additionally, patients treated with ethanol have a 60-75% chance of not experiencing their irregular heartbeat again within a year. These findings suggest that venous ethanol could be a strong option for those with ventricular tachycardia. Participants in this trial may receive venous ethanol combined with endocardial radiofrequency ablation, while others will receive endocardial radiofrequency ablation alone as a control. ^{1 2 4 5 6}

Who Is on the Research Team?

Miguel Valderrabano, MD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8158441/

Alcohol Ablation for Ventricular Tachycardia - PMC OUTCOMES. Our group reported the initial feasibility, efficacy, and safety of retrograde venous ethanol infusion in two small case series.5, 11 Multiple ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1547527125024014

Radiofrequency-aided venous ethanol vs optimized ... 041). In patients with ventricular tachycardia, ventricular tachycardia burden decreased by 96% after CVEA ± RF (P < .0001), while a 70% ...

3. jacc.org jacc.org/doi/10.1016/j.jacep.2020.07.023

Intramural Venous Ethanol Infusion for Refractory ... The aim of this study was to assess the long-term efficacy and outcomes of retrograde venous ethanol ablation in treating ventricular ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.122.011017

Advanced Techniques for Ethanol Ablation of Left ... A prior multicenter study with venous ethanol in ablation refractory VA demonstrated that ethanol alone led to acute success in 76% of patients.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34921464/

Ethanol ablation for ventricular arrhythmias: A systematic ... EA is a valuable therapeutic option for VAs refractory to conventional treatment and can result in 1-year freedom from VA recurrence in 60%-75% of the ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.116.004352

Retrograde Coronary Venous Ethanol Infusion for Ablation ... Conclusions— Retrograde coronary venous ethanol ablation is safe and feasible as a bail-out approach to failed VT RFA, particularly those ...