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Recruiting NCT05511246

Venous Ethanol for Ventricular Tachycardia

Phase II Interventional Ventricular Tachycardia Ischemic Cardiomyopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Venous ethanol, Catheter ablation.
Who it may be relevant to
Registry conditions: Ventricular Tachycardia, Ischemic Cardiomyopathy. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Venous Ethanol for Ischemic Left Ventricular Tachycardia

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

Detailed description

Patients with ventricular tachycardia (VT) in the context of ischemic heart disease suffer from significant morbidity and mortality. Catheter ablation can improve outcomes but has suboptimal ablation results. Ethanol ablation via epicardial veins can add significant therapeutic value to catheter ablation by increasing reach to intramural VT substrates. Investigators will randomize patients with ischemic VT to either endocardial catheter ablation alone, or combined with venous ethanol (VE) ablation of coronary veins located on the epicardial aspect of the VT substrates. A combined primary endpoint: VT recurrence, procedural complications, hospitalization for cardiac causes, and death, will be measured over a 12-month follow-up.

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 outcome measures

  • Ventricular tachycardia recurrence [Time frame: 0-12 months]
  • Hospitalization for cardiac causes [Time frame: 0-12 months]
  • Severe procedural complications [Time frame: 0-12 months]
  • Death [Time frame: 0-12 months]
Secondary outcome measures (12)
  • Procedural time [Time frame: During procedure]
  • Need for unplanned mechanical hemodynamic support [Time frame: During procedure]
  • Repeat ablation procedures, including epicardial [Time frame: 0-12 months]
  • All-cause mortality [Time frame: 0-12 months]
  • Appropriate ICD therapies: antitachycardia pacing and ICD shocks [Time frame: 0-12 months]
  • Inappropriate ICD therapies: antitachycardia pacing and ICD shocks [Time frame: 0-12 months]
  • Change in ICD therapies compared to 3-months pre-randomization [Time frame: 0-12 months]
  • Vt storm [Time frame: 0-12 months]
  • Sustained VT below detection rate [Time frame: 0-12 months]
  • Change in left ventricular ejection fraction (percent) [Time frame: Before and 3 months post-procedure]
  • Quality of life measurement using SF-32 questionnaire [Time frame: 0-12 months]
  • Hospital admission for cardiac causes (including heart failure exacerbation) [Time frame: 0-12 months]

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

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Houston Methodist Hospital — Houston

Identifiers

NCT: NCT05511246 · ADM00021434

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗