Ischemic Cardiomyopathy, Ventricular Tachycardia
Conditions
Keywords
Ventricular tachycardia, Coronary veins, Ethanol, Ablation
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.
Interventions
DRUGVenous ethanol
Cannulation of coronary vein or veins in the VT substrate and balloon injection of ethanol
PROCEDURECatheter ablation
Endocardial catheter ablation of VT substrate
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventricular tachycardia recurrence | 0-12 months | Detection of VT on defibrillator |
| Hospitalization for cardiac causes | 0-12 months | — |
| Severe procedural complications | 0-12 months | Severe procedural complications include bleeding requiring transfusion, stroke or systemic embolization, pericardial tamponade, myocardial infarction, and vascular complications requiring surgery, plus cardiogenic shock requiring unplanned mechanical support. |
| Death | 0-12 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural time | During procedure | Total procedure time (minutes) |
| Need for unplanned mechanical hemodynamic support | During procedure | Unplanned use of intra-aortic balloon pump or ventricular assist device during procedure (Yes/No) |
| Repeat ablation procedures, including epicardial | 0-12 months | Need for repeat procedure (Yes/No) |
| All-cause mortality | 0-12 months | — |
| Appropriate ICD therapies: antitachycardia pacing and ICD shocks | 0-12 months | Presence of appropriate ICD therapies on interrogation |
| Inappropriate ICD therapies: antitachycardia pacing and ICD shocks | 0-12 months | Presence of inappropriate ICD therapies on interrogation |
| Change in ICD therapies compared to 3-months pre-randomization | 0-12 months | Comparison of number of therapies on ICD interrogation |
| Vt storm | 0-12 months | More than 2 episodes of VT within a 24h period |
| Sustained VT below detection rate | 0-12 months | — |
| Change in left ventricular ejection fraction (percent) | Before and 3 months post-procedure | Measured before and 3 months after procedure |
| Quality of life measurement using SF-32 questionnaire | 0-12 months | Scores range from 0 - 100; Lower scores = more disability, higher scores = less disability |
| Hospital admission for cardiac causes (including heart failure exacerbation) | 0-12 months | Hospitalization due to cardiac arrhythmia, heart failure exacerbation and other cardiac causes (yes/no) |
| Antiarrhtyhmic therapy | 0-12 months | Number of antiarrhythmic drugs before and after ablation |
| Freedom from VT after repeat procedures | 0-12 months | Recurrence of VT (yes/no) including patients that have multiple ablations |
| Cardiac transplant or left ventricular assist device implantation | 0-12 months | As a measure of deterioration of cardiac status, requirement of transplant of ventricular assist device implant (yes/no) will be compared |
| Fluoroscopy time | During procedure | Total time of fluoroscopy use (minutes) |
| Total contrast agent used | During procedure | Amount of radiographic contrast used (cc) |
Countries
United States
Contacts
CONTACTIris Melissa Alanis
CONTACTCasey Kappenman
PRINCIPAL_INVESTIGATORMiguel Valderrabano, MD
The Methodist Hospital Research Institute
Outcome results
None listed