Venous Ethanol for Ischemic Left Ventricular Tachycardia

Plain English Summary

Venous Ethanol for Ventricular Tachycardia is a Phase 2 clinical trial sponsored by The Methodist Hospital Research Institute studying Ventricular Tachycardia, Ischemic Cardiomyopathy. This trial tests a new approach for treating a specific type of irregular heartbeat called ventricular tachycardia (VT) in patients with heart muscle damage from a heart attack. It is for adults aged 18-85 who have had a heart attack, have a device to monitor heart rhythm (ICD), and experience frequent VT episodes. Participation involves a procedure where doctors will either perform standard treatment alone or the standard treatment combined with injecting ethanol into a vein near the heart. Alternatives include standard catheter ablation, medications, or device therapy (ICD). The trial aims to enroll 156 participants.

Official Summary

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

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are between 18 and 85 years old, have a history of heart attack, have a heart rhythm monitoring device, and have experienced specific types of irregular heartbeats. You cannot join if you have severe kidney problems, very weak heart pumping function, blood clots in the heart, or certain other serious heart conditions. You also cannot join if you are pregnant, have had recent heart surgery or a heart attack, or have other treatable causes for your irregular heartbeat. This trial is studying Ventricular Tachycardia, Ischemic Cardiomyopathy, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goal is to see if the new treatment reduces the recurrence of irregular heartbeats and hospitalizations for heart problems over a year, meaning patients might experience fewer episodes of VT The specific primary outcome measures are: Ventricular tachycardia recurrence (0-12 months); Hospitalization for cardiac causes (0-12 months); Severe procedural complications (0-12 months); Death (0-12 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial aims to find a better way to treat ventricular tachycardia, a dangerous heart rhythm problem, especially in patients whose hearts are weakened by a heart attack, addressing a gap in current Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Ventricular Tachycardia, Ischemic Cardiomyopathy, where improved treatment options are needed.

Investor Insight

This trial targets a significant unmet need in cardiology, potentially offering a new treatment for a life-threatening condition, which could have commercial value if proven effective and safe. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the risks and benefits of both standard treatment and the new ethanol injection approach. Understand what the procedures involve, including potential discomfort and recovery time. Be prepared for regular follow-up appointments and tests to monitor your heart's condition. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: TRIPLE
• Enrollment: 156 participants

Interventions

• DRUG: Venous ethanol — Cannulation of coronary vein or veins in the VT substrate and balloon injection of ethanol
• PROCEDURE: Catheter ablation — Endocardial catheter ablation of VT substrate

Primary Outcomes

• Ventricular tachycardia recurrence (0-12 months)
• Hospitalization for cardiac causes (0-12 months)
• Severe procedural complications (0-12 months)
• Death (0-12 months)

Secondary Outcomes

• Procedural time (During procedure)
• Need for unplanned mechanical hemodynamic support (During procedure)
• Repeat ablation procedures, including epicardial (0-12 months)
• All-cause mortality (0-12 months)
• Appropriate ICD therapies: antitachycardia pacing and ICD shocks (0-12 months)

Full Eligibility Criteria

Inclusion Criteria:

* Male and female, ages of 18 and 85 years and with a prior ICD implant
* Diagnosed with ischemic cardiomyopathy: Prior myocardial infarction (pathological Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause)
* One of the following VT events (within last 6 months): a) ≥3 episodes of VT treated with anti-tachycardia pacing (ATP) or anti-arrhythmic drugs; b) ≥1 appropriate ICD shocks; c) ≥3 VT episodes within 24 hr; d) sustained VT below detection rate of the ICD documented by EKG/cardiac monitor
* Patients deemed candidates for RF ablation of VT
* Able and willing to comply with pre-, post-, and follow-up requirements
* Willing to sign the informed consent

Exclusion Criteria:

* Serum creatinine \>1.5 mg/dL, or creatinine clearance \<30 ml/min
* Left ventricular (LV) ejection fraction ≤10%
* Mobile LV thrombus on echocardiography
* Absence of vascular access to the LV
* Disease process likely to limit survival to \<12 months
* New York Heart Association class IV heart failure
* Cardiac surgery within the past 2 months (unless VT was incessant),
* Acute coronary syndrome in the past 2 months (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on EKG)
* Another reversible cause of VT (e.g. electrolyte abnormalities, drug-induced arrhythmia)
* Severe aortic stenosis or mitral regurgitation with a flail leaflet
* Pregnancy
* Unwilling or unable to provide informed consent
* Covid-19 positive testing within 14 days of randomization procedure
* Enrolled, or planning to get enrolled, in another research study during his/her participation on the Velvet trial

Trial Locations

• Houston Methodist Hospital, Houston, Texas, United States

Frequently Asked Questions

Related Conditions

• Ventricular Tachycardia
• Ischemic Cardiomyopathy
• Heart Attack
• Arrhythmia
• Heart Failure
• Coronary Artery Disease
• Cardiomyopathy
• Sudden Cardiac Arrest
• Atrial Fibrillation
• Heart Palpitations

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