Using venous ethanol to improve treatment for ventricular tachycardia
Venous Ethanol for Ischemic Left Ventricular Tachycardia
This study is testing if adding venous ethanol to standard heart treatment can help people with ventricular tachycardia feel better and reduce their chances of having problems in the future.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | The Methodist Hospital Research Institute Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05511246 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the effectiveness of standard catheter ablation with a novel approach that includes venous ethanol ablation for patients suffering from ischemic ventricular tachycardia. Participants will be randomized to receive either traditional endocardial catheter ablation alone or the combined treatment with venous ethanol targeting coronary veins. The study aims to assess the recurrence of ventricular tachycardia, procedural complications, hospitalizations, and mortality over a 12-month follow-up period. This approach seeks to enhance the reach of ablation therapy to improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with ischemic cardiomyopathy and a history of ventricular tachycardia events.
Not a fit: Patients with severe renal impairment, very low left ventricular ejection fraction, or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the recurrence of ventricular tachycardia and improve overall survival rates for patients with ischemic cardiomyopathy.
How similar studies have performed: While catheter ablation is a well-established treatment, the use of venous ethanol in this context is a novel approach that has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- Houston Methodist Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Miguel Valderrabano, MD — The Methodist Hospital Research Institute
- Study coordinator: Iris Melissa Alanis
- Email: imalanis@houstonmethodist.org
- Phone: 7134416548
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.