Cardiac Sympathetic Denervation for Prevention of Ventricular Tachyarrhythmias

NCT01013714 | Unknown Phase 3 DMC

• 1 other identifier: UCLA09-07-100-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time to ICD shock, death, or cardiac transplantation

  To compare the time to first occurrence of appropriate ICD shock, death or cardiac transplantation in CSD+routine care vs. routine care groups.

  7 months

Secondary Outcomes (5)

• Number of ICD shocks

  7 months

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

  7 months

• Serious adverse events

  7 months

• Number and etiology of hospitalizations

  7 months

• Number of deaths or cardiac transplantations

  7 months

Study Arms (2)

Routine Care + Cardiac Sympathetic Denervation (CSD)

ACTIVE COMPARATOR

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.

Procedure: Cardiac Sympathetic Denervation (CSD); Drug: Routine Care

Routine Care

PLACEBO COMPARATOR

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.

Drug: Routine Care

Interventions

Cardiac Sympathetic Denervation (CSD) PROCEDURE

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 + Cardiac Sympathetic Denervation (CSD)

Routine Care DRUG

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.

Routine Care; Routine Care + Cardiac Sympathetic Denervation (CSD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)).
• 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.
• Patient is taking at least one anti-arrhythmic drug or has documented intolerance or toxicity to at least one anti-arrhythmic drug.
• years of age or older at time of enrollment
• Able and willing to comply with all pre- and follow-up testing and requirements.
• Provision of signed informed consent and stated willingness to comply with all study procedures for duration of the study.

You may not qualify if:

• Any medical or non-medical condition likely to prevent completion of trial.
• 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.
• Left ventricular assist device or status post orthotopic heart transplantation
• Severe thrombocytopenia (platelets \< 50,000) or Coagulopathy (INR \> 2.0) that is not due to medications or a reversible cause.
• Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).
• Unable or unwilling to comply with protocol requirements.
• NYHA class IV heart failure symptoms.
• Known channelopathy such as long QT syndrome and catecholaminergic polymorphic VT.
• Clinical VT rate \< 150 bpm

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Oregon Health and Science University: collaborator

Study Sites (3)

UCLA Health

Los Angeles, California, 90095, United States

RECRUITING

OHSU

Portland, Oregon, 97239, United States

RECRUITING

Vanderbilt University

Nashville, Tennessee, 37235, United States

RECRUITING

Related Publications (14)

• Mahajan A, Moore J, Cesario DA, Shivkumar K. Use of thoracic epidural anesthesia for management of electrical storm: a case report. Heart Rhythm. 2005 Dec;2(12):1359-62. doi: 10.1016/j.hrthm.2005.09.004. No abstract available.

  PMID: 16360091 BACKGROUND

• Stephenson EA, Berul CI. Electrophysiological interventions for inherited arrhythmia syndromes. Circulation. 2007 Aug 28;116(9):1062-80. doi: 10.1161/CIRCULATIONAHA.106.655779. No abstract available.

  PMID: 17724272 BACKGROUND

• Nademanee K, Taylor R, Bailey WE, Rieders DE, Kosar EM. Treating electrical storm : sympathetic blockade versus advanced cardiac life support-guided therapy. Circulation. 2000 Aug 15;102(7):742-7. doi: 10.1161/01.cir.102.7.742.

  PMID: 10942741 BACKGROUND

• Tygesen H, Wettervik C, Claes G, Drott C, Emanuelsson H, Solem J, Lomsky M, Radberg G, Wennerblom B. Long-term effect of endoscopic transthoracic sympathicotomy on heart rate variability and QT dispersion in severe angina pectoris. Int J Cardiol. 1999 Aug 31;70(3):283-92. doi: 10.1016/s0167-5273(99)00101-1.

  PMID: 10501343 BACKGROUND

• Schwartz PJ, Priori SG, Cerrone M, Spazzolini C, Odero A, Napolitano C, Bloise R, De Ferrari GM, Klersy C, Moss AJ, Zareba W, Robinson JL, Hall WJ, Brink PA, Toivonen L, Epstein AE, Li C, Hu D. Left cardiac sympathetic denervation in the management of high-risk patients affected by the long-QT syndrome. Circulation. 2004 Apr 20;109(15):1826-33. doi: 10.1161/01.CIR.0000125523.14403.1E. Epub 2004 Mar 29.

  PMID: 15051644 BACKGROUND

• Li J, Wang L, Wang J. Video-assisted thoracoscopic sympathectomy for congenital long QT syndromes. Pacing Clin Electrophysiol. 2003 Apr;26(4 Pt 1):870-3. doi: 10.1046/j.1460-9592.2003.t01-1-00152.x.

  PMID: 12715848 BACKGROUND

• Ouriel K, Moss AJ. Long QT syndrome: an indication for cervicothoracic sympathectomy. Cardiovasc Surg. 1995 Oct;3(5):475-8. doi: 10.1016/0967-2109(95)94444-2.

  PMID: 8574528 BACKGROUND

• Lobato EB, Kern KB, Paige GB, Brown M, Sulek CA. Differential effects of right versus left stellate ganglion block on left ventricular function in humans: an echocardiographic analysis. J Clin Anesth. 2000 Jun;12(4):315-8. doi: 10.1016/s0952-8180(00)00158-6.

  PMID: 10960205 BACKGROUND

• Schlack W, Dinter W. Haemodynamic effects of a left stellate ganglion block in ASA I patients. An echocardiographic study. Eur J Anaesthesiol. 2000 Feb;17(2):79-84. doi: 10.1046/j.1365-2346.2000.00606.x.

  PMID: 10758450 BACKGROUND

• Bourke T, Vaseghi M, Michowitz Y, Sankhla V, Shah M, Swapna N, Boyle NG, Mahajan A, Narasimhan C, Lokhandwala Y, Shivkumar K. Neuraxial modulation for refractory ventricular arrhythmias: value of thoracic epidural anesthesia and surgical left cardiac sympathetic denervation. Circulation. 2010 Jun 1;121(21):2255-62. doi: 10.1161/CIRCULATIONAHA.109.929703. Epub 2010 May 17.

  PMID: 20479150 BACKGROUND

• Ajijola OA, Vaseghi M, Mahajan A, Shivkumar K. Bilateral cardiac sympathetic denervation: why, who and when? Expert Rev Cardiovasc Ther. 2012 Aug;10(8):947-9. doi: 10.1586/erc.12.93. No abstract available.

  PMID: 23030281 BACKGROUND

• Johnson JP, Ahn SS, Choi WC, Masciopinto JE, Kim KD, Filler AG, Desalles AA. Thoracoscopic sympathectomy: techniques and outcomes. Neurosurg Focus. 1998 Feb 15;4(2):e4. doi: 10.3171/foc.1998.4.2.7.

  PMID: 17206769 BACKGROUND

• Vaseghi M, Gima J, Kanaan C, Ajijola OA, Marmureanu A, Mahajan A, Shivkumar K. Cardiac sympathetic denervation in patients with refractory ventricular arrhythmias or electrical storm: intermediate and long-term follow-up. Heart Rhythm. 2014 Mar;11(3):360-6. doi: 10.1016/j.hrthm.2013.11.028. Epub 2013 Nov 28.

  PMID: 24291775 BACKGROUND

• Vaseghi M, Barwad P, Malavassi Corrales FJ, Tandri H, Mathuria N, Shah R, Sorg JM, Gima J, Mandal K, Saenz Morales LC, Lokhandwala Y, Shivkumar K. Cardiac Sympathetic Denervation for Refractory Ventricular Arrhythmias. J Am Coll Cardiol. 2017 Jun 27;69(25):3070-3080. doi: 10.1016/j.jacc.2017.04.035.

  PMID: 28641796 BACKGROUND

MeSH Terms

Conditions

Death, Sudden, Cardiac; Tachycardia, Ventricular; Ventricular Fibrillation; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Arrhythmias, Cardiac; Cardiac Conduction System Disease

Study Officials

• Marmar Vaseghi, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marmar Vaseghi, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine/Cardiology

Study Record Dates

• First Submitted: November 13, 2009
• First Posted: November 16, 2009
• Study Start: July 26, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 3 years

Locations

US (3)