CyberHeart's Cardiac Arrhythmia Ablation Treatment: Patients With Refractory Ventricular Tachycardia/Fibrillation

Study Overview
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Brief Summary
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The objective of this clinical investigation is to evaluate: 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. 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.

Detailed Description
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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.

Official Title
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CyberHeart's Cardiac Arrhythmia Ablation Treatment: Patients With Refractory Ventricular Tachycardia

Conditions
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Tachycardia, Ventricular

Intervention / Treatment
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* Device: CyberHeart System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of an implantable cardioverter-defibrillator (ICD) 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. 60 years of age or greater. Left ventricular ejection fraction ≥ 20%. Failure of or ineligible for catheter ablation. Exclusion Criteria: Unable or unwilling to provide informed consent Patients with idiopathic VT Women who are pregnant Prior radiation therapy to the thorax Active ischemia or other reversible causes of VT Active non-cardiovascular illness or systemic infection Presence of thrombus in the right atrium or right ventricle on pre-procedure echocardiogram Cardiogenic shock NYHA (New York Heart Association) Class IV Heart Failure. Presence of incessant VT that is hemodynamically unstable. Acute heart failure exacerbation. Revascularization in the past 90 days. Other disease process that is likely to limit survival to less than 12 months

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open label<br>Non-randomized, open label clinical trial that intends to treat 10 subjects with refractory ventricular tachycardia with the CyberHeart system using standard radiosurgical techniques. | Device: CyberHeart System<br>* The CyberHeart system uses proprietary software to assist the cardiologist to contour ablation targets. Standard radiosurgical techniques are then used to accomplish ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months (360 days) with Outcome assesment in first 30 days adn in days 31 to 1 year post treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 12 months | 
| Left ventricular function post treatment | Left ventricular systolic and diastolic function will be assessed by echocardiography pre- and post treatment | 12 months |