Surgery to prevent dangerous heart rhythms

Prophylactic Cardiac Sympathetic Denervation for Prevention of Ventricular Tachyarrhythmias (PREVENT VT)

This study is testing if a surgery that removes certain nerves can help people with implantable defibrillators avoid dangerous heart rhythms and improve their quality of life.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, Los Angeles (Academic / other)
• Locations: 3 sites (Los Angeles, California and 2 other locations)
• Trial ID: NCT01013714 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of cardiac sympathetic denervation (CSD) surgery in preventing life-threatening heart rhythms, specifically ventricular tachycardia and ventricular fibrillation, in patients with implantable cardioverter defibrillators (ICDs). Participants will have a history of recurrent ventricular tachycardia despite previous catheter ablation procedures or will have types of arrhythmias that cannot be treated with ablation. The CSD procedure involves the removal of specific ganglia that are believed to contribute to these abnormal rhythms. The study aims to determine if this surgical intervention can reduce the occurrence of ICD shocks and improve patients' quality of life.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with recurrent ventricular tachycardia who have undergone at least one catheter ablation procedure or have arrhythmias that are not amenable to ablation.

Not a fit: Patients who do not have recurrent ventricular tachycardia or who are not candidates for ICD placement may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the frequency of painful ICD shocks and improve the quality of life for patients with recurrent ventricular tachycardia.

How similar studies have performed: Previous studies have shown promising results with similar surgical approaches, indicating potential for success in this novel application.

Eligibility criteria

INCLUSION CRITERIA

1. Appropriate ICD shock for VT after at least one catheter ablation of VT procedure, OR appropriate ICD shock for VT and underwent electrophysiology study/ablation procedure where the procedure was not successful (i.e. determined that VT comes from an inaccessible location or VT was not inducible and could not be targeted or continued to have inducible VT at the end of the procedure) OR appropriate ICD shock for VT and not a candidate for VT ablation (i.e. patients with presence polymorphic VT or ventricular fibrillation, LV thrombus)).
2. 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.
3. Patient is taking at least one anti-arrhythmic drug or has documented intolerance or toxicity to at least one anti-arrhythmic drug.
4. 18 years of age or older at time of enrollment
5. Able and willing to comply with all pre- and follow-up testing and requirements.
6. Provision of signed informed consent and stated willingness to comply with all study procedures for duration of the study.

EXCLUSION CRITERIA

1. Active ongoing cardiac ischemia as assessed by: ECG, cardiac enzymes, symptoms, coronary angiography with evidence of significant epicardial coronary stenosis (\>70%), or stress testing. (Note: positive troponin assay due to ICD shocks is not an exclusion criterion).
2. Any medical or non-medical condition likely to prevent completion of trial.
3. Contraindication to cardiac sympathetic denervation (i.e. unlikely to tolerate general anesthesia, single-lung ventilation, severe pulmonary disease, or severe pulmonary hypertension) or previous cardiac sympathetic denervation procedure.
4. Left ventricular assist device or status post orthotopic heart transplantation
5. Severe thrombocytopenia (platelets \< 50,000) or Coagulopathy (INR \> 2.0) that is not due to medications or a reversible cause.
6. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).
7. Unable or unwilling to comply with protocol requirements.
8. NYHA class IV heart failure symptoms.
9. Known channelopathy such as long QT syndrome and catecholaminergic polymorphic VT.
10. Clinical VT rate \< 150 bpm

Where this trial is running

Los Angeles, California and 2 other locations

• UCLA Health — Los Angeles, California, United States (Recruiting)
• Ohsu — Portland, Oregon, United States (Recruiting)
• Vanderbilt University — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Principal investigator: Marmar Vaseghi, MD, PhD — University of California, Los Angeles
• Study coordinator: Marmar Vaseghi, MD, PhD

Conditions Sudden Cardiac Death; Ventricular Tachycardia; Ventricular Fibrillation; Cardiomyopathy; Sudden cardiac death; Ventricular tachycardia; Ventricular fibrillation; Internal cardiac defibrillator shocks