Recruiting
Phase 3

Cardiac Sympathetic Denervation

Sponsor:

UCLA

Code:

NCT01013714

Conditions

Sudden Cardiac Death

Ventricular Tachycardia

Ventricular Fibrillation

Cardiomyopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cardiac Sympathetic Denervation (CSD)

Routine Care

Study Details

Brief summary:

The purpose of this research study is to examine the effect of cardiac sympathetic denervation (CSD) surgery on life threatening abnormal heart rhythms called ventricular tachycardia or ventricular fibrillation that can lead to sudden cardiac death. Subjects will be asked to participate in this research study if they have recurrent ventricular tachycardia (at least one ICD shock for ventricular tachycardia) and have undergone at least one catheter ablation procedure or have ventricular tachycardia or fibrillation that is not ablatable. The goal of this study is to determine whether cardiac sympathetic denervation can prevent these abnormal heart rhythms from occurring and therefore, prevent, ICD shocks which are not only painful, but have been shown to reduce quality of life and/or lead to depression, particularly in the period immediately after the shock.

Conditions

Sudden Cardiac Death

Ventricular Tachycardia

Ventricular Fibrillation

Cardiomyopathy

Study ID

NCT01013714

Start date

Jul 26, 2021

Status verified date

Jan, 2024

Completion date

Aug 31, 2024

Anticipated

Primary completion date

Aug 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Routine Care + Cardiac Sympathetic Denervation (CSD)

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.

placebo comparator: Routine Care

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.

Interventions

Cardiac Sympathetic Denervation (CSD)

Cardiac sympathetic denervation is performed using an endoscopic procedure called VATS (video-assisted thoracoscopic sympathectomy). The surgeon removes the lower half of the stellate ganglia in addition to the thoracic ganglia of T2 - T4 on both the right and left side. The VATS procedure provides a minimally invasive endoscopic approach that is safe and effective. The procedure can be completed in less than 45 minutes on each side.

Routine Care

Anti-arrhythmic medications are continued for the duration of the study unless discontinued or adjusted to due to drug toxicity, intolerance, or ICD shock. All anti-arrhythmic medications (whether in the routine care or surgical arm) can be adjusted at the discretion of the treating physician.

Primary outcome measure

  • Time to ICD shock, death, or cardiac transplantation [ Time Frame: 7 months ]

Central Contacts and Locations

Central contacts

Locations

UCLA Health

Recruiting

Los Angeles, California, United States, 90095

Contacts

Marmar M Vaseghi, MD, PhD

310-206-2235mvaseghi@mednet.ucla.edu

Principal Investigator:

Marmar Vaseghi, MD, PhD

OHSU

Recruiting

Portland, Oregon, United States, 97239

Contacts

Saket Sanghai, MD

sanghai@ohsu.edu

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37235

Contacts

More Information

Sponsor

University of California, Los Angeles

Last update posted

Jan 19, 2024

Last verified

Jan, 2024

Keywords

  • Sudden cardiac death
  • Ventricular tachycardia
  • Ventricular fibrillation
  • Cardiomyopathy
  • Internal cardiac defibrillator shocks
  • Internal cardiac defibrillator therapies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2024-01-19.