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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Endocardial radiofrequency ablation of ventricular tachycardia |
|
| Venous ethanol | Experimental | Endocardial radiofrequency ablation of ventricular tachycardia combined with venous ethanol ablation of the tachycardia substrate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venous ethanol | Drug | Cannulation of coronary vein or veins in the VT substrate and balloon injection of ethanol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ventricular tachycardia recurrence | Detection of VT on defibrillator | 0-12 months |
| Hospitalization for cardiac causes | 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. | 0-12 months |
| Death | 0-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural time | Total procedure time (minutes) | During procedure |
| Need for unplanned mechanical hemodynamic support | Unplanned use of intra-aortic balloon pump or ventricular assist device during procedure (Yes/No) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Iris Melissa Alanis | Contact | 7134416548 | imalanis@houstonmethodist.org | |
| Casey Kappenman | Contact | 3462382367 | cjkappenman@houstonmethodist.org |
| Name | Affiliation | Role |
|---|---|---|
| Miguel Valderrabano, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
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| Catheter ablation | Procedure | Endocardial catheter ablation of VT substrate |
|
| During procedure |
| Repeat ablation procedures, including epicardial | Need for repeat procedure (Yes/No) | 0-12 months |
| All-cause mortality | 0-12 months |
| Appropriate ICD therapies: antitachycardia pacing and ICD shocks | Presence of appropriate ICD therapies on interrogation | 0-12 months |
| Inappropriate ICD therapies: antitachycardia pacing and ICD shocks | Presence of inappropriate ICD therapies on interrogation | 0-12 months |
| Change in ICD therapies compared to 3-months pre-randomization | Comparison of number of therapies on ICD interrogation | 0-12 months |
| Vt storm | More than 2 episodes of VT within a 24h period | 0-12 months |
| Sustained VT below detection rate | 0-12 months |
| Change in left ventricular ejection fraction (percent) | Measured before and 3 months after procedure | 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 | 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) | 0-12 months |
| Antiarrhtyhmic therapy | Number of antiarrhythmic drugs before and after ablation | 0-12 months |
| Freedom from VT after repeat procedures | Recurrence of VT (yes/no) including patients that have multiple ablations | 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 | 0-12 months |
| Fluoroscopy time | Total time of fluoroscopy use (minutes) | During procedure |
| Total contrast agent used | Amount of radiographic contrast used (cc) | During procedure |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 |
| Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |