Venous Ethanol for Ventricular Tachycardia

Description

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

Conditions

Ventricular Tachycardia, Ischemic Cardiomyopathy

Study Overview

Study Details

Study overview

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

Venous Ethanol for Ischemic Left Ventricular Tachycardia

Venous Ethanol for Ventricular Tachycardia

Condition
Ventricular Tachycardia
Intervention / Treatment

-

Contacts and Locations

Houston

Houston Methodist Hospital, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Methodist Hospital Research Institute,

Miguel Valderrabano, MD, PRINCIPAL_INVESTIGATOR, The Methodist Hospital Research Institute

Study Record Dates

2028-12-12