Ventricular TachycardiaPhase 2VELVETNCT05511246
Venous Ethanol for Ventricular Tachycardia
A Phase 2 study testing Venous ethanol and Catheter ablation in people with Ventricular Tachycardia and Ischemic Cardiomyopathy, run by The Methodist Hospital Research Institute at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ventricular Tachycardia, Ischemic Cardiomyopathy
- What is being tested?
- Venous ethanol and Catheter ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2023to 12 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Disease process likely to limit survival to <12 months
- New York Heart Association class IV heart failure
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Chinwe Ngumezi, RN, 346-238-0290, ccngumezi@houstonmethodist.org
Iris Melissa Alanis, 7134416548, imalanis@houstonmethodist.org
About this study
Official title: Venous Ethanol for Ischemic Left Ventricular Tachycardia
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
Read the 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.
- Conditions
- Ventricular Tachycardia, Ischemic Cardiomyopathy
- Being tested
- Venous ethanol, Catheter ablation
- Keywords
- Ventricular tachycardia, Coronary veins, Ethanol, Ablation
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous ethanolDrug
Also called Alcohol
Cannulation of coronary vein or veins in the VT substrate and balloon injection of ethanol
Catheter ablationProcedure or surgery
Endocardial catheter ablation of VT substrate
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Endocardial radiofrequency ablation of ventricular tachycardia Receives: Procedure: Catheter ablation |
| Venous ethanol | Experimental | Endocardial radiofrequency ablation of ventricular tachycardia combined with venous ethanol ablation of the tachycardia substrate Receives: Drug: Venous ethanol; Procedure: Catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular tachycardia recurrence
Detection of VT on defibrillator
Measured: 0-12 months
Hospitalization for cardiac causes
Measured: 0-12 months
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.
Measured: 0-12 months
Death
Measured: 0-12 months
Secondary outcomes (17)
Procedural time
Total procedure time (minutes)
Measured: During procedure
Need for unplanned mechanical hemodynamic support
Unplanned use of intra-aortic balloon pump or ventricular assist device during procedure (Yes/No)
Measured: During procedure
Repeat ablation procedures, including epicardial
Need for repeat procedure (Yes/No)
Measured: 0-12 months
All-cause mortality
Measured: 0-12 months
Appropriate ICD therapies: antitachycardia pacing and ICD shocks
Presence of appropriate ICD therapies on interrogation
Measured: 0-12 months
Inappropriate ICD therapies: antitachycardia pacing and ICD shocks
Presence of inappropriate ICD therapies on interrogation
Measured: 0-12 months
Change in ICD therapies compared to 3-months pre-randomization
Comparison of number of therapies on ICD interrogation
Measured: 0-12 months
Vt storm
More than 2 episodes of VT within a 24h period
Measured: 0-12 months
Sustained VT below detection rate
Measured: 0-12 months
Change in left ventricular ejection fraction (percent)
Measured before and 3 months after procedure
Measured: Before and 3 months post-procedure
Quality of life measurement using SF-32 questionnaire
Scores range from 0 - 100; Lower scores = more disability, higher scores = less disability
Measured: 0-12 months
Hospital admission for cardiac causes (including heart failure exacerbation)
Hospitalization due to cardiac arrhythmia, heart failure exacerbation and other cardiac causes (yes/no)
Measured: 0-12 months
Antiarrhtyhmic therapy
Number of antiarrhythmic drugs before and after ablation
Measured: 0-12 months
Freedom from VT after repeat procedures
Recurrence of VT (yes/no) including patients that have multiple ablations
Measured: 0-12 months
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
Measured: 0-12 months
Fluoroscopy time
Total time of fluoroscopy use (minutes)
Measured: During procedure
Total contrast agent used
Amount of radiographic contrast used (cc)
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start12 Apr 2023
- Primary completion12 Dec 2027 (estimated)
- Study completion12 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miguel Valderrabano, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511246
- Sponsor's protocol ID
- ADM00021434
- Acronym
- VELVET
- Status last verified
- Jul 2026
- First submitted
- 8 Aug 2022
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Ethanol for Ischemic Left Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT05511246
- Acronym / sponsor ID
- VELVET / ADM00021434
- Conditions
- Ventricular Tachycardia, Ischemic Cardiomyopathy
- Keywords
- Ventricular tachycardia, Coronary veins, Ethanol, Ablation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 12 Dec 2027 (estimated)
- Study completion
- 12 Dec 2028 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Catheter ablationEndocardial radiofrequency ablation of ventricular tachycardia |
| Venous ethanol | Experimental | Drug: Venous ethanol, Procedure: Catheter ablationEndocardial radiofrequency ablation of ventricular tachycardia combined with venous ethanol ablation of the tachycardia substrate |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
- Disease process likely to limit survival to <12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous ethanolAlso: AlcoholCannulation of coronary vein or veins in the VT substrate and balloon injection of ethanol | Drug | Venous ethanol |
| Catheter ablationEndocardial catheter ablation of VT substrate | Procedure or surgery | Control, Venous ethanol |
Primary outcome
Ventricular tachycardia recurrence
Time frame: 0-12 months
Detection of VT on defibrillator
Hospitalization for cardiac causes
Time frame: 0-12 months
Severe procedural complications
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.
Death
Time frame: 0-12 months
17 secondary outcomes
Procedural time
Time frame: During procedure
Need for unplanned mechanical hemodynamic support
Time frame: During procedure
Repeat ablation procedures, including epicardial
Time frame: 0-12 months
All-cause mortality
Time frame: 0-12 months
Appropriate ICD therapies: antitachycardia pacing and ICD shocks
Time frame: 0-12 months
Inappropriate ICD therapies: antitachycardia pacing and ICD shocks
Time frame: 0-12 months
Change in ICD therapies compared to 3-months pre-randomization
Time frame: 0-12 months
Vt storm
Time frame: 0-12 months
Sustained VT below detection rate
Time frame: 0-12 months
Change in left ventricular ejection fraction (percent)
Time frame: Before and 3 months post-procedure
Quality of life measurement using SF-32 questionnaire
Time frame: 0-12 months
Hospital admission for cardiac causes (including heart failure exacerbation)
Time frame: 0-12 months
Antiarrhtyhmic therapy
Time frame: 0-12 months
Freedom from VT after repeat procedures
Time frame: 0-12 months
Cardiac transplant or left ventricular assist device implantation
Time frame: 0-12 months
Fluoroscopy time
Time frame: During procedure
Total contrast agent used
Time frame: During procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Ventricular Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
Active, not recruiting
Combined Pulsed Field and Radiofrequency Energy for Ablation of Ventricular Tachycardia
Ventricular Tachycardia (V-Tach)
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miguel Valderrabano, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Venous ethanol and Catheter ablation in people with Ventricular Tachycardia and Ischemic Cardiomyopathy, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iris Melissa Alanis (7134416548, imalanis@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventricular tachycardia recurrence (time frame: 0-12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.