Cardiac Denervation Surgery for Prevention of Ventricular Tachycardia (PREVENT VT)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this research study is to examine the effect of cardiac denervation surgery, otherwise known as bilateral cervico-thoracic sympathectomy, 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 trial if they have had 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 bilateral cervicothoracic sympathectomy 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sudden Cardiac Death Ventricular Tachycardia Ventricular Fibrillation Cardiomyopathy |
Procedure: Bilateral cervicothoracic sympathectomy Drug: ICD, medical therapy, and catheter ablation of VT only |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Prophylactic Bilateral Cervicothoracic Sympathectomy for Prevention of Ventricular Tachycardia |
- Survival free from any appropriate ICD shock 72 hours after sympathectomy procedure. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Freedom from any appropriate ICD therapy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Freedom from Composite of Death and ICD shocks [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Freedom from VT ablation procedure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Freedom from Death [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Frequency of ICD therapies [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Trend in ICD shocks [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 216 |
| Study Start Date: | July 2013 |
| Estimated Study Completion Date: | July 2017 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Sympathectomy + medical therapy + ICD
Bilateral cervicothoracic sympathectomy will be performed in patients randomized to the Active Therapy Arm/ Any clinically approved endoscopic method of sympathectomy with removal of the lower half of the bilateral cervical stellate ganglia and T2-T4 ganglia is acceptable. All patients meeting the inclusion criteria of this study will have undergone or will undergo an ICD placement based on ACC/AHA criteria. All participants will have had at least one ICD shock despite having a catheter ablation of VT performed prior to enrollment. If patient has a recurrent ICD shock while enrolled in the study, repeat VT ablation procedure, as indicated, can be performed. Follow-up Visits
|
Procedure: Bilateral cervicothoracic sympathectomy
Bilateral cervicothoracic sympathectomy which involves endoscopic removal of the lower one third to one half of the stellate ganglia together with the thoracic ganglia of T2 - T4 provides adequate cardiac denervation with no or minimal Horner's syndrome in long QT syndrome and recurrent angina. Though this procedure has been traditionally performed under general anesthesia most commonly using a supraclavicular approach, endoscopic techniques are now available, reducing both the duration and invasiveness of the procedure and hospitalization. Video-assisted thoracoscopic sympathectomy provides a minimally invasive endoscopic approach to this procedure that is safe and effective. Furthermore, the procedure can be completed in less than 45 minutes per side.
|
|
Placebo Comparator: Standard medical therapy, ICD
Patients assigned to this arm will not undergo denervation therapy (sympathectomy). All patients meeting the inclusion criteria of this study and randomized to the placebo arm will have undergone or will undergo an ICD based on ACC/AHA criteria. If patient has a recurrent ICD shock while enrolled, a repeat VT ablation procedure as clinically indicated, can be performed.
Follow-up Visits
|
Drug: ICD, medical therapy, and catheter ablation of VT only
Patients assigned to this arm will receive ACC/AHA guideline recommended therapies for heart failure only and will undergo/will have already undergone ICD placement as indicated for their heart failure. Furthermore, they will be considered for catheter ablation of their arrhythmia and will undergo catheter ablation of their ventricular arrhythmias prior to randomization.
|
Detailed Description:
The purpose of this research study is to examine the effect of a procedure called bilateral cervicothoracic sympathectomy which involves removal of part of the cervical stellate ganglia and thoracic ganglia of level 2 to 4. These ganglia house the left and right sided nerves that feed the heart and have been implicated in the occurrence of fast abnormal rhythms that cause defibrillator shocks and sudden death. Stimulation of these nerves has been shown to increase the incidence of sudden death and fast abnormal heart rhythms that lead to internal defibrillator shocks called ventricular tachycardia/ventricular fibrillation. Removal of the ganglia of these nerves in animal and human studies has been shown to decrease the incidence of life threatening abnormal rhythms and sudden death. The purpose of this study is to examine whether this procedure along with an internal defibrillator and current maximum medical therapy can reduce the incidence of these life threatening abnormal rhythms as compared to an internal defibrillator and medical therapy alone.
We are inviting patients to participate in this clinical trial who have undergone at least one catheter ablation procedure for ventricular tachycardia but have continued to experience recurrent arrhythmias or who have a type of ventricular tachycardia or fibrillation that can not be treated with catheter ablation procedures. You maybe randomized to receive the procedure and an internal defibrillator (if you don't have one already) plus maximum medical therapy to receive the defibrillator and medical therapy and catheter ablation. The procedure involves removal of part of the bilateral ganglia of the nerves that feed the heart. This procedure takes less than 45 minutes on each side and can be performed endoscopically.
We are asking 226 individuals (approximate age range 18-80 years) who continue to experience ICD shocks despite at least one catheter ablation procedure to participate in this research trial but only half these individual will be randomized under the bilateral cervicothoracic sympathectomy.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Any cardiomyopathy and at least one ICD shock after at least 1 VT ablation procedure or ventricular tachycardia or ventricular fibrillation that is not ablatable.
If ischemic, MI occurred more than one month before enrollment. ICD implantation with at least 1 ICD shock. Age greater than 18 years old.
Exclusion Criteria:
- Active ongoing cardiac ischemia as assessed by EKG, cardiac enzymes, symptoms, coronary angiography with evidence of significant epicardial coronary stenosis (>70%), stress testing showing evidence of ischemia.
Revascularization in the past 90 days.
- Incessant ventricular tachycardia
- Contraindication to sympathectomy.
- Any medical or non-medical condition likely to prevent completion of trial.
- Slow VT, rate < 120 bpm.
- History of LVAD or BIVAD.
- Pregnancy
- Inability to give consent.
Contacts and Locations| Contact: Kalyanam Shivkumar, MD, PhD | 310-206-2235 | kshivkumar@mednet.ucla.edu |
| Contact: Marmar Vaseghi, MD | 310-206-2235 | mvaseghi@mednet.ucla.edu |
| United States, California | |
| UCLA | Not yet recruiting |
| Los Angeles, California, United States, 90065 | |
| Contact: Michelle Betwarda, M.S. 310-206-2235 mbetwarda@mednet.ucla.edu | |
| Contact: Marmar Vaseghi, MD 310-206-2235 mvaseghi@mednet.ucla.edu | |
| Principal Investigator: Kalyanam Shivkumar, MD, PhD | |
| Sub-Investigator: Marmar Vaseghi, MD | |
| Principal Investigator: | Kalyanam Shivkumar, MD, PhD | University of California Los Angeles Cardiac Arrhythmia Center |
| Principal Investigator: | Marmar Vaseghi, MD MS | University of California, Los Angeles |
More Information
Publications:
| Responsible Party: | Marmar Vaseghi, Assistant Professor, University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT01013714 History of Changes |
| Other Study ID Numbers: | UCLA09-07-100-01 |
| Study First Received: | November 13, 2009 |
| Last Updated: | January 3, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Los Angeles:
|
Sudden cardiac death Ventricular tachycardia Ventricular fibrillation |
Cardiomyopathy Internal cardiac defibrillator shocks Internal cardiac defibrillator therapies |
Additional relevant MeSH terms:
|
Death Tachycardia Ventricular Fibrillation Tachycardia, Ventricular Death, Sudden, Cardiac Cardiomyopathies |
Pathologic Processes Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Heart Arrest Death, Sudden |
ClinicalTrials.gov processed this record on June 18, 2013