NCT02661048

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Varian, a Siemens Healthineers Company · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Tachycardia, Ventricular

Interventions

Type	Name	Description
DEVICE	CyberHeart System	The CyberHeart system uses proprietary software to assist the cardiologist to contour ablation targets. Standard radiosurgical techniques are then used to accomplish ablation

Timeline

• Start date: 2015-02-27
• Primary completion: 2023-07-06
• Completion: 2023-07-06
• First posted: 2016-01-21
• Last updated: 2023-09-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study