Clinical trial NCT05511246: Venous Ethanol for Ventricular Tachycardia
Official title: Venous Ethanol for Ischemic Left Ventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ventricular Tachycardia
Ischemic Cardiomyopathy
Keywords: Ventricular tachycardia
Coronary veins
Ethanol
Ablation
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

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

Primary outcomes:
measure: Ventricular tachycardia recurrence
timeFrame: 0-12 months
measure: Hospitalization for cardiac causes
timeFrame: 0-12 months
measure: Severe procedural complications
timeFrame: 0-12 months
measure: Death
timeFrame: 0-12 months
Secondary outcomes:
measure: Procedural time
timeFrame: During procedure
measure: Need for unplanned mechanical hemodynamic support
timeFrame: During procedure
measure: Repeat ablation procedures, including epicardial
timeFrame: 0-12 months
measure: All-cause mortality
timeFrame: 0-12 months
measure: Appropriate ICD therapies: antitachycardia pacing and ICD shocks
timeFrame: 0-12 months
measure: Inappropriate ICD therapies: antitachycardia pacing and ICD shocks
timeFrame: 0-12 months
measure: Change in ICD therapies compared to 3-months pre-randomization
timeFrame: 0-12 months
measure: Vt storm
timeFrame: 0-12 months
measure: Sustained VT below detection rate
timeFrame: 0-12 months
measure: Change in left ventricular ejection fraction (percent)
timeFrame: Before and 3 months post-procedure
measure: Quality of life measurement using SF-32 questionnaire
timeFrame: 0-12 months
measure: Hospital admission for cardiac causes (including heart failure exacerbation)
timeFrame: 0-12 months
measure: Antiarrhtyhmic therapy
timeFrame: 0-12 months
measure: Freedom from VT after repeat procedures
timeFrame: 0-12 months
measure: Cardiac transplant or left ventricular assist device implantation
timeFrame: 0-12 months
measure: Fluoroscopy time
timeFrame: During procedure
measure: Total contrast agent used
timeFrame: During procedure
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Miguel Valderrabano, MD
role: PRINCIPAL_INVESTIGATOR
References: