Houston Methodist Hospital
Houston, Texas, 77030, United States
Location status: Recruiting
Location contact
Chinwe Ngumezi, RN
CONTACT
Iris Melissa Alanis
CONTACT
Miguel Valderrabano, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05511246
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
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Phase 2
Houston, Texas, 77030, United States
Location status: Recruiting
Chinwe Ngumezi, RN
CONTACT
Iris Melissa Alanis
CONTACT
Miguel Valderrabano, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cannulation of coronary vein or veins in the VT substrate and balloon injection of ethanol
Other names: Alcohol
Endocardial catheter ablation of VT substrate
Time frame: 0-12 months
Detection of VT on defibrillator
Time frame: 0-12 months
Time frame: 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.
Time frame: 0-12 months
Time frame: During procedure
Total procedure time (minutes)
Time frame: During procedure
Unplanned use of intra-aortic balloon pump or ventricular assist device during procedure (Yes/No)
Time frame: 0-12 months
Need for repeat procedure (Yes/No)
Time frame: 0-12 months
Time frame: 0-12 months
Presence of appropriate ICD therapies on interrogation
Time frame: 0-12 months
Presence of inappropriate ICD therapies on interrogation
Time frame: 0-12 months
Comparison of number of therapies on ICD interrogation
Time frame: 0-12 months
More than 2 episodes of VT within a 24h period
Time frame: 0-12 months
Time frame: Before and 3 months post-procedure
Measured before and 3 months after procedure
Time frame: 0-12 months
Scores range from 0 - 100; Lower scores = more disability, higher scores = less disability
Time frame: 0-12 months
Hospitalization due to cardiac arrhythmia, heart failure exacerbation and other cardiac causes (yes/no)
Time frame: 0-12 months
Number of antiarrhythmic drugs before and after ablation
Time frame: 0-12 months
Recurrence of VT (yes/no) including patients that have multiple ablations
Time frame: 0-12 months
As a measure of deterioration of cardiac status, requirement of transplant of ventricular assist device implant (yes/no) will be compared
Time frame: During procedure
Total time of fluoroscopy use (minutes)
Time frame: During procedure
Amount of radiographic contrast used (cc)
Contact information is provided by the study sponsor or research team.
Casey Kappenman
CONTACT
Iris Melissa Alanis
CONTACT
The Methodist Hospital Research Institute
Other
Venous Ethanol for Ischemic Left Ventricular Tachycardia
Acronym: VELVET
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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