VELVET: Venous Ethanol for Ventricular Tachycardia

Sponsor

The Methodist Hospital Research Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05511246

Collaborator

(none)

156

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ventricular Tachycardia Ischemic Cardiomyopathy	Drug: Venous ethanol Procedure: Catheter ablation	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

156 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Venous Ethanol for Ischemic Left Ventricular Tachycardia

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2027

Anticipated Study Completion Date :

Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Endocardial radiofrequency ablation of ventricular tachycardia	Procedure: Catheter ablation Endocardial catheter ablation of VT substrate
Experimental: Venous ethanol Endocardial radiofrequency ablation of ventricular tachycardia combined with venous ethanol ablation of the tachycardia substrate	Drug: Venous ethanol Cannulation of coronary vein or veins in the VT substrate and balloon injection of ethanol Other Names: Alcohol Procedure: Catheter ablation Endocardial catheter ablation of VT substrate

Arm

Intervention/Treatment

Active Comparator: Control

Endocardial radiofrequency ablation of ventricular tachycardia

Procedure: Catheter ablation

Endocardial catheter ablation of VT substrate

Experimental: Venous ethanol

Endocardial radiofrequency ablation of ventricular tachycardia combined with venous ethanol ablation of the tachycardia substrate

Drug: Venous ethanol

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

Other Names:

Alcohol

Procedure: Catheter ablation

Endocardial catheter ablation of VT substrate

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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