Using venous ethanol to improve treatment for ventricular tachycardia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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:

* Creatinine clearance \<25 cc/min (using Cockcroft-Gault equation) except for patients on dialysis. (Contrast induced nephropathy is irrelevant in end-stage renal disease patients on dialysis, in whom the concern for contrast-induced renal dysfunction is not there since there is no chance of further kidney damage). Additionally, patients on dialysis will be excluded from the imaging sub-study.
* 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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ablation Index-guided treatment for ventricular tachycardia in heart disease patients

  This study tests whether using a new technology to guide heart procedures can help people with heart disease and fast heartbeats feel better and have fewer problems later on compared to standard methods.

  Recruiting Rush University Medical Center · Chicago, Illinois and 4 other locations · NCT06138873

• HB1011: a first-in-human test of heart-derived stem cells injected during bypass surgery

  This study tests whether a heart-derived stem cell therapy called HB1011 is safe to use during CABG surgery for people with ischemic cardiomyopathy.

  Recruiting Phase 1 HieraBio Inc. · Seongnam-si, Gyeonggi-do · NCT07861035

• AI-powered ECG to help diagnose and locate tachycardia in patients with PSVT, WPW, PVC, or VT

  A multicenter registry test whether an AI-enabled ECG analysis can help diagnose and localize tachycardia in adults with certain arrhythmias.

  Recruiting Inha University Hospital · Incheon, Incheon · NCT07859020

• Targeted ablation to block scar channels that cause ventricular tachycardia

  This study tests whether targeted radiofrequency ablation of scar-channel exits can prevent ventricular tachycardia in patients with scarred hearts.

  Recruiting New York Medical College · Valhalla, New York · NCT07814079

• DuoVT PFA System for Treating Ventricular Tachycardia

  This study tests whether the DuoVT Pulsed Field Ablation system can safely and effectively treat Ventricular Tachycardia in people with ischemic heart disease.

  Recruiting at 2 sites Abbott Medical Devices · Split, Dalmtia and 4 other locations · NCT07706712

• Sphere VT: Using Sphere-9 Catheter and Affera System to treat recurrent scar-related ventricular tachycardia

  This study tests the Sphere-9 catheter and Affera mapping and ablation system in adults with recurring scar-related ventricular tachycardia after a prior heart attack.

  Recruiting at 5 sites Medtronic Cardiac Ablation Solutions · Littleton, Colorado and 6 other locations · NCT07585968

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.