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The objective of this clinical investigation is to evaluate:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label | Experimental | Non-randomized, open label clinical trial that intends to treat 10 subjects with refractory ventricular tachycardia with the CyberHeart system using standard radiosurgical techniques. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CyberHeart System | Device | The CyberHeart system uses proprietary software to assist the cardiologist to contour ablation targets. Standard radiosurgical techniques are then used to accomplish ablation |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claire McCann | Varian Medical Systems | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26082532 | Result | Loo BW Jr, Soltys SG, Wang L, Lo A, Fahimian BP, Iagaru A, Norton L, Shan X, Gardner E, Fogarty T, Maguire P, Al-Ahmad A, Zei P. Stereotactic ablative radiotherapy for the treatment of refractory cardiac ventricular arrhythmia. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):748-50. doi: 10.1161/CIRCEP.115.002765. No abstract available. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 15, 2026 | |
| Reset | May 6, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 15, 2026 | May 6, 2026 |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |