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

Completed · Not applicable

Conditions studied: Tachycardia, Ventricular

In brief

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.

Key facts

Study ID

NCT02661048

Run by

Varian, a Siemens Healthineers Company

People needed

5

Starts

2015-02-27

Expected to finish

2023-07-06

Last updated by the study team

2023-09-07

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States

Full record on ClinicalTrials.gov

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