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

Who is this study for? Patients with structural heart disease
What treatments are being studied? Cardiac Sympathetic Denervation
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
UCLA Health
RECRUITING
Los Angeles
Oregon
OHSU
RECRUITING
Portland
Tennessee
Vanderbilt University
RECRUITING
Nashville
Contact Information
Primary
Marmar Vaseghi, MD, PhD
mvaseghi@mednet.ucla.edu
310-206-2235
Time Frame
Start Date: 2021-07-26
Estimated Completion Date: 2024-08-31
Participants
Target number of participants: 40
Treatments
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.
Sponsors
Leads: University of California, Los Angeles
Collaborators: Oregon Health and Science University

This content was sourced from clinicaltrials.gov