RECRUITING

Venous Ethanol for Ventricular Tachycardia

Conditions

Ventricular Tachycardia Ischemic Cardiomyopathy Coronary veins Ethanol Ablation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Venous Ethanol for Ischemic Left Ventricular Tachycardia

Quick Facts

Study Start:2023-04-12

Study Completion:2028-12-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05511246

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Rene Plascencia

CONTACT

7134416548

rplascencia@houstonmethodist.org

Casey Kappenman

CONTACT

3462382367

cjkappenman@houstonmethodist.org

Principal Investigator

Miguel Valderrabano, MD

PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Study Locations (Sites)

Houston Methodist Hospital

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: The Methodist Hospital Research Institute

Miguel Valderrabano, MD, PRINCIPAL_INVESTIGATOR, The Methodist Hospital Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-12

Study Completion Date2028-12-12

Study Record Updates

Study Start Date2023-04-12

Study Completion Date2028-12-12

Terms related to this study

Keywords Provided by Researchers

Ventricular tachycardia
Coronary veins
Ethanol
Ablation

Additional Relevant MeSH Terms

Ventricular Tachycardia
Ischemic Cardiomyopathy