Cardiac Sympathetic Denervation for Prevention of Ventricular Tachyarrhythmias

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Nov 13, 2009

Keywords

ClinConnect Summary

This clinical trial is studying a surgical procedure called cardiac sympathetic denervation (CSD) to see if it can help prevent dangerous heart rhythms, like ventricular tachycardia and ventricular fibrillation, which can lead to sudden cardiac death. These abnormal heart rhythms can cause painful shocks from an implantable cardioverter-defibrillator (ICD), which is a device that helps control heart rhythms. The trial is looking for participants who have experienced at least one shock from their ICD due to ventricular tachycardia, especially if they have had previous treatments that didn't work or if they are not candidates for other procedures.

To be eligible for this trial, participants should be 18 years or older, have a specific type of heart issue, and be currently taking or have had issues with heart rhythm medications. Participants will need to agree to follow the study's requirements and procedures. If you join the trial, you will receive the CSD surgery and be monitored to see how it affects your heart rhythms and overall well-being. This study aims to improve quality of life for people who frequently experience these heart issues.

Gender

ALL

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