Venous Ethanol for Ventricular Tachycardia

Ventricular Tachycardia Clinical Trial

— VELVET  

Official title:

Venous Ethanol for Ischemic Left Ventricular Tachycardia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05511246
• Other study ID #: ADM00021434
• Status: Recruiting
• Phase: Phase 2
• Start date: April 12, 2023
• Est. completion date: December 12, 2028

Study information

• Verified date: December 2023
• Source: The Methodist Hospital Research Institute
• Contact: Rene Plascencia
• Phone: 7134416548
• Email: rplascencia[@]houstonmethodist.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: December 12, 2028
• Est. primary completion date: December 12, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Ischemic Cardiomyopathy
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

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

Locations

Country	Name	City	State
United States	Houston Methodist Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The Methodist Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventricular tachycardia recurrence	Detection of VT on defibrillator	0-12 months
Primary	Hospitalization for cardiac causes		0-12 months
Primary	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.	0-12 months
Primary	Death		0-12 months
Secondary	Procedural time	Total procedure time (minutes)	During procedure
Secondary	Need for unplanned mechanical hemodynamic support	Unplanned use of intra-aortic balloon pump or ventricular assist device during procedure (Yes/No)	During procedure
Secondary	Repeat ablation procedures, including epicardial	Need for repeat procedure (Yes/No)	0-12 months
Secondary	All-cause mortality		0-12 months
Secondary	Appropriate ICD therapies: antitachycardia pacing and ICD shocks	Presence of appropriate ICD therapies on interrogation	0-12 months
Secondary	Inappropriate ICD therapies: antitachycardia pacing and ICD shocks	Presence of inappropriate ICD therapies on interrogation	0-12 months
Secondary	Change in ICD therapies compared to 3-months pre-randomization	Comparison of number of therapies on ICD interrogation	0-12 months
Secondary	Vt storm	More than 2 episodes of VT within a 24h period	0-12 months
Secondary	Sustained VT below detection rate		0-12 months
Secondary	Change in left ventricular ejection fraction (percent)	Measured before and 3 months after procedure	Before and 3 months post-procedure
Secondary	Quality of life measurement using SF-32 questionnaire	Scores range from 0 - 100; Lower scores = more disability, higher scores = less disability	0-12 months
Secondary	Hospital admission for cardiac causes (including heart failure exacerbation)	Hospitalization due to cardiac arrhythmia, heart failure exacerbation and other cardiac causes (yes/no)	0-12 months
Secondary	Antiarrhtyhmic therapy	Number of antiarrhythmic drugs before and after ablation	0-12 months
Secondary	Freedom from VT after repeat procedures	Recurrence of VT (yes/no) including patients that have multiple ablations	0-12 months
Secondary	Cardiac transplant or left ventricular assist device implantation	As a measure of deterioration of cardiac status, requirement of transplant of ventricular assist device implant (yes/no) will be compared	0-12 months
Secondary	Fluoroscopy time	Total time of fluoroscopy use (minutes)	During procedure
Secondary	Total contrast agent used	Amount of radiographic contrast used (cc)	During procedure