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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

Must not have

Contraindication to cardiac sympathetic denervation or previous cardiac sympathetic denervation procedure

Active ongoing cardiac ischemia as assessed by ECG, cardiac enzymes, symptoms, coronary angiography with evidence of significant epicardial coronary stenosis (>70%), or stress testing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 months

Awards & highlights

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot undergo or have already had a heart nerve surgery.

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I do not have active heart problems as shown by tests.

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I am willing and able to follow study rules.

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I have a heart condition affecting my heart's electrical activity.

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I have severe heart failure symptoms.

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I have severe low platelet count or blood clotting issues not caused by medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to ICD shock, death, or cardiac transplantation

Secondary study objectives

Number and etiology of hospitalizations

Number of ICD shocks

Number of appropriate ICD therapies (including ATPs ) and sustained VT below ICD detection

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 12Eligibility criteria met