Routine Care + Cardiac Sympathetic Denervation (CSD) for Ventricular Fibrillation

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Ventricular Fibrillation+8 More
Cardiac Sympathetic Denervation (CSD) - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is examining whether surgery to rid the heart of nerves that trigger abnormal rhythms can prevent ICD shocks, which are painful and linked to reduced quality of life.

Eligible Conditions
  • Ventricular Fibrillation
  • Sudden Death, Cardiac
  • Tachycardia, Ventricular
  • Cardiomyopathy

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 7 months

7 months
Number and etiology of hospitalizations
Number of ICD shocks
Number of appropriate ICD therapies (including ATPs ) and sustained VT below ICD detection
Number of deaths or cardiac transplantations
Serious adverse events
Time to ICD shock, death, or cardiac transplantation

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Routine Care + Cardiac Sympathetic Denervation (CSD)
1 of 2
Routine Care
1 of 2

Active Control

Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: Routine Care + Cardiac Sympathetic Denervation (CSD) · Has Placebo Group · Phase 3

Routine Care
Drug
PlaceboComparator Group · 1 Intervention: Routine Care · Intervention Types: Drug
Routine Care + Cardiac Sympathetic Denervation (CSD)ActiveComparator Group · 2 Interventions: Cardiac Sympathetic Denervation (CSD), Routine Care · Intervention Types: Procedure, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 7 months

Who is running the clinical trial?

Vanderbilt UniversityOTHER
682 Previous Clinical Trials
6,131,421 Total Patients Enrolled
University of California, Los AngelesLead Sponsor
1,404 Previous Clinical Trials
6,941,009 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,055 Previous Clinical Trials
30,975,374 Total Patients Enrolled
1 Trials studying Ventricular Fibrillation
800 Patients Enrolled for Ventricular Fibrillation
Kalyanam Shivkumar, MD, PhDPrincipal InvestigatorUniversity of California, Los Angeles
2 Previous Clinical Trials
10,006 Total Patients Enrolled
Marmar Vaseghi, MD, PhDPrincipal Investigator - University of California, Los Angeles
Resnick Neuropsychiatric Hospital at UCLA

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are eligible for the study if you are between the ages of 18 and 75 years old.
You are able and willing to comply with all pre- and follow-up testing and requirements.
You are willing to comply with all study procedures for the duration of the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: November 16th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References