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Venous Ethanol for Ventricular Tachycardia

ConditionsVentricular TachycardiaIschemic Cardiomyopathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorThe Methodist Hospital Research Institute

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Venous ethanol

    Drug

    Cannulation of coronary vein or veins in the VT substrate and balloon injection of ethanol

  • Catheter ablation

    Procedure/Surgery

    Endocardial catheter ablation of VT substrate

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: Venous ethanolExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Ventricular tachycardia recurrence

Detection of VT on defibrillator

Time frame
0-12 months
2

Hospitalization for cardiac causes

Time frame
0-12 months
3

Severe procedural complications

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.

Time frame
0-12 months
4

Death

Time frame
0-12 months

Secondary outcomes

1

Procedural time

Total procedure time (minutes)

Time frame
During procedure
2

Need for unplanned mechanical hemodynamic support

Unplanned use of intra-aortic balloon pump or ventricular assist device during procedure (Yes/No)

Time frame
During procedure
3

Repeat ablation procedures, including epicardial

Need for repeat procedure (Yes/No)

Time frame
0-12 months
4

All-cause mortality

Time frame
0-12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Methodist Hospital Research Institute

Lead sponsor

Source ClinicalTrials.gov
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