Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
156 participants
INTERVENTIONAL
2023-04-12
2028-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Control
Endocardial radiofrequency ablation of ventricular tachycardia
Catheter ablation
Endocardial catheter ablation of VT substrate
Venous ethanol
Endocardial radiofrequency ablation of ventricular tachycardia combined with venous ethanol ablation of the tachycardia substrate
Venous ethanol
Cannulation of coronary vein or veins in the VT substrate and balloon injection of ethanol
Catheter ablation
Endocardial catheter ablation of VT substrate
Interventions
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Venous ethanol
Cannulation of coronary vein or veins in the VT substrate and balloon injection of ethanol
Catheter ablation
Endocardial catheter ablation of VT substrate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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The Methodist Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Miguel Valderrabano, MD
Role: PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute
Locations
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Houston Methodist Hospital
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ADM00021434
Identifier Type: -
Identifier Source: org_study_id
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