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Procedure
CSD for Ventricular Tachycardia (PREVENT VT Trial)
Phase 3
Recruiting
Led By Kalyanam Shivkumar, MD, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of structural heart disease as defined as EF ≤ 50% or presence of ventricular scar as detected by imaging modalities or electroanatomic mapping, hypertrophic cardiomyopathy, cardiac sarcoidosis, or arrhythmogenic right ventricular cardiomyopathy
Patients with appropriate ICD shock for VT after at least one catheter ablation of VT procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 months
Awards & highlights
PREVENT VT Trial Summary
This trial is examining whether surgery to rid the heart of nerves that trigger abnormal rhythms can prevent ICD shocks, which are painful and linked to reduced quality of life.
Who is the study for?
This trial is for adults with heart disease, specifically those who have had a painful ICD shock due to ventricular tachycardia and are not candidates for VT ablation. Participants must be on anti-arrhythmic drugs or intolerant to them, and able to follow the study procedures. Pregnant women, individuals with severe heart failure or conditions preventing trial completion, and those who can't tolerate the surgery are excluded.Check my eligibility
What is being tested?
The study tests if cardiac sympathetic denervation (CSD) surgery can prevent life-threatening abnormal heart rhythms in patients with recurrent ventricular tachycardia or fibrillation. It aims to see if CSD can reduce ICD shocks that lower quality of life and cause depression.See study design
What are the potential side effects?
Potential side effects of CSD may include complications from general anesthesia, issues related to single-lung ventilation during surgery, as well as risks associated with any surgical procedure such as infection or bleeding.
PREVENT VT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have heart disease with an EF of 50% or less, or a diagnosed heart condition.
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I had a shock from my ICD for VT after a catheter ablation.
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I received a shock from my ICD for VT and cannot have VT ablation.
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I am currently on an anti-arrhythmic drug or have had a bad reaction to one.
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I am 18 years old or older.
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My heart device activated for a fast rhythm and my procedure to fix it didn't work.
PREVENT VT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to ICD shock, death, or cardiac transplantation
Secondary outcome measures
Number and etiology of hospitalizations
Number of ICD shocks
Number of appropriate ICD therapies (including ATPs ) and sustained VT below ICD detection
+2 morePREVENT VT Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Routine Care + Cardiac Sympathetic Denervation (CSD)Active Control2 Interventions
Patients in this arm receive routine care and undergo cardiac sympathetic denervation. The procedure must be scheduled to occur within one month of randomization.
Follow-up Visits
Follow up at 4 weeks after optimization of medical therapy and surgery
All patients are followed at the ICD clinic at 7 months or as needed.
Information regarding ICD therapy and arrhythmias will be obtained from ICD interrogations at the follow up visits.
Monthly phone calls will be used to determine for interval events, including presence of side-effects.
VT Ablation is permitted in both arms for ICD shock after optimization.
Group II: Routine CarePlacebo Group1 Intervention
Patients in this arm remain on prescribed drug regimen and will not undergo CSD.
Follow-up Visits
Medical follow up at 4 weeks after optimization of medical therapy.
All patients are followed at the ICD clinic at 7 months or as needed.
Information regarding ICD therapy and arrhythmias will be obtained from ICD interrogations at the follow up visits.
Monthly phone calls will be used to determine for interval events, including presence of side-effects.
VT Ablation is permitted in both arms for ICD shock after optimization.
Find a Location
Who is running the clinical trial?
Oregon Health and Science UniversityOTHER
976 Previous Clinical Trials
7,386,229 Total Patients Enrolled
Vanderbilt UniversityOTHER
704 Previous Clinical Trials
6,143,323 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,269 Previous Clinical Trials
14,838,602 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many willing test subjects are required for this experiment?
"This study needs 40 patients that meet the given conditions in order to proceed. People who want to help with this research can do so by enrolling at different sites, such as Johns Hopkins University or Vanderbilt University."
Answered by AI
Does the FDA condone combining routine care with Cardiac Sympathetic Denervation?
"This routine care + Cardiac Sympathetic Denervation (CSD) intervention has been studied in Phase 3 trials, so it has received a safety score of 3 from our team."
Answered by AI
Can people with the required medical conditions join this clinical trial at this time?
"That is correct. The clinical trial described on clinicaltrials.gov is looking for 40 patients from 4 different sites. The trial was posted on 7/26/2021 and was last updated on 8/31/2021."
Answered by AI
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