CyberHeart's Cardiac Arrhythmia Ablation Treatment: Patients With Refractory Ventricular Tachycardia/Fibrillation
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|ClinicalTrials.gov Identifier: NCT02661048|
Recruitment Status : Recruiting
First Posted : January 21, 2016
Last Update Posted : April 5, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Tachycardia, Ventricular||Device: CyberHeart System||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CyberHeart's Cardiac Arrhythmia Ablation Treatment: Patients With Refractory Ventricular Tachycardia|
|Actual Study Start Date :||February 27, 2015|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||January 31, 2024|
Experimental: Open label
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
The CyberHeart system uses proprietary software to assist the cardiologist to contour ablation targets. Standard radiosurgical techniques are then used to accomplish ablation
- Outcome 1 is the Number of participants with Treatment related Serious Adverse Events as assessed by CTCAE v. 4.0 [ Time Frame: 12 months (360 days) with Outcome assesment in first 30 days adn in days 31 to 1 year post treatment. ]
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.
- Number of participants with a change in SF-36 Medical Outcomes Health Survey, as compared to pre-treatment questionaire responses [ Time Frame: 12 months ]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
- Number of defibrillation shocks as compared to pretreatment occurrence [ Time Frame: 12 months ]Defibrillation shocks will be recorded pre-treatment and post treatment at each follow-up visit.
- Ventricular arrhythmia episodes, as compared to pretreatment occurrence [ Time Frame: 12 months ]The number of ventricular tachycardia episodes that required either anti-tachycardia pacing, or that self-terminated, will be recorded pre- and post treatment.
- Left ventricular function post treatment [ Time Frame: 12 months ]Left ventricular systolic and diastolic function will be assessed by echocardiography pre- and post treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02661048
|Contact: Patrick Maguire, MD PhDemail@example.com|
|Contact: Edward Gardner, PhDfirstname.lastname@example.org|
|United States, California|
|El Camino Hospital||Recruiting|
|Mountain View, California, United States, 94040|
|Contact: Travis Stewart, BS 650-691-4896 email@example.com|
|Principal Investigator: Daniel W Kaiser, MD|
|United States, Texas|
|Texas Cardiac Arrhythmia Research Foundation||Recruiting|
|Austin, Texas, United States, 78705|
|Contact: Deb Cardinal, RN 512-458-9410 Deb Cardinal <firstname.lastname@example.org>|
|Principal Investigator: Amin Al-ahmad, MD|
|Study Director:||Patrick Maguire, MD PhD||CyberHeart Inc.|