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Radiosurgery
CyberHeart System for Ventricular Tachycardia
N/A
Waitlist Available
Research Sponsored by Varian Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with ischemic or non-ischemic cardiomyopathy who have had recurrent symptomatic VT that induced ICD shock(s) following catheter ablation and/or antiarrhythmic drug (AAD) therapy.
Failure of or ineligible for catheter ablation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is to study the safety and efficacy of the CyberHeart System in treating patients with refractory ventricular tachycardia (VT) using the CyberKnife Radiosurgical System.
Eligible Conditions
- Ventricular Tachycardia
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You cannot have or are not eligible for a procedure called catheter ablation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Outcome 1 is the Number of participants with Treatment related Serious Adverse Events as assessed by CTCAE v. 4.0
Secondary outcome measures
Left ventricular function post treatment
Number of defibrillation shocks as compared to pretreatment occurrence
Number of participants with a change in SF-36 Medical Outcomes Health Survey, as compared to pre-treatment questionaire responses
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Open labelExperimental Treatment1 Intervention
Non-randomized, open label clinical trial that intends to treat 10 subjects with refractory ventricular tachycardia with the CyberHeart system using standard radiosurgical techniques.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CyberHeart System
2015
N/A
~10
Find a Location
Who is running the clinical trial?
Varian MedicalLead Sponsor
6 Previous Clinical Trials
325 Total Patients Enrolled
Varian, a Siemens Healthineers CompanyLead Sponsor
30 Previous Clinical Trials
7,268 Total Patients Enrolled
Claire McCannStudy DirectorVarian Medical Systems
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot have or are not eligible for a procedure called catheter ablation.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any opportunities to join this clinical experiment?
"According to data housed on clinicaltrials.gov, this research initiative is not presently recruiting participants. The trial was initially posted in February 2015 and last edited May 2020; however there are 181 alternative studies currently seeking volunteers."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Texas Cardiac Arrhythmia Research Foundation
What portion of applicants met pre-screening criteria?
Did not meet criteria
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