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

Primary Purpose

Sudden Cardiac Death, Ventricular Tachycardia, Ventricular Fibrillation

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Cardiac Sympathetic Denervation (CSD)

Routine Care

About this trial

This is an interventional treatment trial for Sudden Cardiac Death focused on measuring Sudden cardiac death, Ventricular tachycardia, Ventricular fibrillation, Cardiomyopathy, Internal cardiac defibrillator shocks, Internal cardiac defibrillator therapies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA

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.
18 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.

EXCLUSION CRITERIA

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).
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

Sites / Locations

UCLA HealthRecruiting
OHSURecruiting
Vanderbilt UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Routine Care + Cardiac Sympathetic Denervation (CSD)

Routine Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of ICD shocks

To compare the number of ICD shocks in patients with Routine Care + CSD to Routine Care.

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

To compare the number of appropriate ICD therapies and VT episodes below ICD detection in patients with Routine Care + CSD to Routine Care.

Serious adverse events

To assess the occurrence of serious adverse events in patients treated with Routine Care + CSD and Routine Care.

Number and etiology of hospitalizations

Number and etiology of hospitalization will be compared in the control vs. intervention group.

Number of deaths or cardiac transplantations

Number of deaths or cardiac transplantation in both arms of the study will be compared.

Full Information

NCT ID

NCT01013714

First Posted

November 13, 2009

Last Updated

January 9, 2023

Sponsor

University of California, Los Angeles

Collaborators

Vanderbilt University, Oregon Health and Science University

1. Study Identification

Unique Protocol Identification Number

NCT01013714

Brief Title

Cardiac Sympathetic Denervation for Prevention of Ventricular Tachyarrhythmias

Acronym

PREVENT VT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 26, 2021 (Actual)

Primary Completion Date

August 31, 2023 (Anticipated)

Study Completion Date

August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

Collaborators

Vanderbilt University, Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The purpose of this study is to determine if bilateral cardiac sympathetic denervation (CSD) in addition to routine care is more effective than routine care for the treatment of ventricular tachycardia or fibrillation in patients with implantable cardioverter defibrillators (ICDs) who continue to have episodes of VT despite drug therapy and when appropriate, at least one catheter ablation procedure. The CSD procedure 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 procedure takes less than 45 minutes on each side and can be performed endoscopically. 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 (ICD shocks) or who have a type of ventricular tachycardia or fibrillation that can not be treated with catheter ablation procedures. Patients will be randomized in a 1:1 fashion to either routine care + cardiac sympathetic denervation (CSD) or routine care without cardiac sympathetic denervation. We are asking 40 individuals (approximate age range 18-80 years) who continue to experience ICD shocks to participate in this research study but only half these individual will be randomized to cardiac sympathetic denervation (CSD) surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Routine Care + Cardiac Sympathetic Denervation (CSD)

Arm Type

Active Comparator

Arm Description

Arm Title

Routine Care

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Cardiac Sympathetic Denervation (CSD)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Routine Care

Intervention Description

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 Information:

Title

Time to ICD shock, death, or cardiac transplantation

Description

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

Time Frame

7 months

Secondary Outcome Measure Information:

Title

Number of ICD shocks

Description

To compare the number of ICD shocks in patients with Routine Care + CSD to Routine Care.

Time Frame

7 months

Title

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

Description

To compare the number of appropriate ICD therapies and VT episodes below ICD detection in patients with Routine Care + CSD to Routine Care.

Time Frame

7 months

Title

Serious adverse events

Description

To assess the occurrence of serious adverse events in patients treated with Routine Care + CSD and Routine Care.

Time Frame

7 months

Title

Number and etiology of hospitalizations

Description

Number and etiology of hospitalization will be compared in the control vs. intervention group.

Time Frame

7 months

Title

Number of deaths or cardiac transplantations

Description

Number of deaths or cardiac transplantation in both arms of the study will be compared.

Time Frame

7 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA 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. 18 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. EXCLUSION CRITERIA 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). 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marmar Vaseghi, MD, PhD

Phone

310-206-2235

mvaseghi@mednet.ucla.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marmar Vaseghi, MD, PhD

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCLA Health

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marmar M Vaseghi, MD, PhD

Phone

310-206-2235

mvaseghi@mednet.ucla.edu

First Name & Middle Initial & Last Name & Degree

Marmar Vaseghi, MD, PhD

First Name & Middle Initial & Last Name & Degree

Kalyanam Shivkumar, MD, PhD

Facility Name

OHSU

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Saket Sanghai, MD

sanghai@ohsu.edu

Facility Name

Vanderbilt University

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37235

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arvindh Kanagasundram, MD

arvindh.n.kanagasundram@vanderbilt.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Deidentified data will be shared with other investigators upon request.

IPD Sharing Time Frame

3 years

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Cardiac Sympathetic Denervation for Prevention of Ventricular Tachyarrhythmias

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