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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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 more

Trial 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

0 / 2Eligibility criteria met

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

CyberHeart System (Radiosurgery) Clinical Trial Eligibility Overview. Trial Name: NCT02661048 — N/A

CyberHeart System (Radiosurgery) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02661048 — N/A

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