The objective of this clinical investigation is to evaluate: 1. the safety and efficacy of the CyberHeart System, CardioPlan™ Software and Laptop, in treating patients with refractory ventricular tachycardia (VT) using the CyberKnife® Radiosurgical System. 2. The CyberHeart System performance with respect to the ability to contour myocardial targets that are transferred to the Multi-plan® Treatment Planning Software of the CyberKnife® system for the production and delivery of a safe radiosurgical treatment plan. Cardiac radiosurgery is a minimally-non invasive, painless, procedure. Tissue ablation can be accomplished precisely.
This study is a prospective, multi-center (2), single arm, open label US-based feasibility study. The clinical hypothesis for the study is that the CyberHeart treatment approach will be safe and with further study will not be shown to be inferior to current treatment options, may lead to a survival benefit and improved quality of life. The ablation to be performed with the CyberHeart System will be targeting the anatomical site of the clinically presenting VT. The application site will be determined by morphological criteria on the 12 lead ECG along with anatomical data from MRI or CT scan imaging. Ablation will be performed at the designated location with the intention to produce substrate modification. The Study will enroll a maximum of 10 patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
The CyberHeart system uses proprietary software to assist the cardiologist to contour ablation targets. Standard radiosurgical techniques are then used to accomplish ablation
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Outcome 1 is the Number of participants with Treatment related Serious Adverse Events as assessed by CTCAE v. 4.0
Outcome 1 is measured by The number of Participants, and the percentage of participants with : \- Serious Adverse Events; (1) in the first 30 days, (2) in days 31 to 1 year post treatment, both treatment related, and non-treatment related, separately tabulated.
Time frame: 12 months (360 days) with Outcome assesment in first 30 days adn in days 31 to 1 year post treatment.
Number of participants with a change in SF-36 Medical Outcomes Health Survey, as compared to pre-treatment questionaire responses
Participants will complete a SF-36 (Short Form-36) Medical Outcomes Survey before treatment and at each post treatment follow-up check. Absolute numeric numbers will be tabulated and percentage change will be calculated
Time frame: 12 months
Number of defibrillation shocks as compared to pretreatment occurrence
Defibrillation shocks will be recorded pre-treatment and post treatment at each follow-up visit.
Time frame: 12 months
Ventricular arrhythmia episodes, as compared to pretreatment occurrence
The number of ventricular tachycardia episodes that required either anti-tachycardia pacing, or that self-terminated, will be recorded pre- and post treatment.
Time frame: 12 months
Left ventricular function post treatment
Left ventricular systolic and diastolic function will be assessed by echocardiography pre- and post treatment
Time frame: 12 months
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