Tachycardia, VentricularNCT02661048
CyberHeart's Cardiac Arrhythmia Ablation Treatment: Patients With Refractory Ventricular Tachycardia/Fibrillation
A study testing CyberHeart System in people with Tachycardia, Ventricular, run by Varian, a Siemens Healthineers Company at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Tachycardia, Ventricular
- What is being tested?
- CyberHeart System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2015to 6 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
About this study
Official title: CyberHeart's Cardiac Arrhythmia Ablation Treatment: Patients With Refractory Ventricular Tachycardia
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.
Read the 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
- Being tested
- CyberHeart System
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyberHeart SystemDevice
The CyberHeart system uses proprietary software to assist the cardiologist to contour ablation targets. Standard radiosurgical techniques are then used to accomplish ablation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CyberHeart System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months (360 days) with Outcome assesment in first 30 days adn in days 31 to 1 year post treatment.
Secondary outcomes (4)
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
Measured: 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.
Measured: 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.
Measured: 12 months
Left ventricular function post treatment
Left ventricular systolic and diastolic function will be assessed by echocardiography pre- and post treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study start27 Feb 2015
- Primary completion6 Jul 2023
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tachycardia, VentricularStudies of the same condition, open and under way.
- More trials run by Varian, a Siemens Healthineers CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Varian, a Siemens Healthineers Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claire McCann, Study director, Varian Medical Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661048
- Sponsor's protocol ID
- CyberHeart Inc. -001
- Status last verified
- Sep 2023
- First submitted
- 22 Dec 2015
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 26082532
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CyberHeart's Cardiac Arrhythmia Ablation Treatment: Patients With Refractory Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT02661048
- Acronym / sponsor ID
- CyberHeart Inc. -001
- Conditions
- Tachycardia, Ventricular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Varian, a Siemens Healthineers CompanyIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2015 (actual)
- Primary completion
- 6 Jul 2023 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 21 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label | Experimental | Device: CyberHeart SystemNon-randomized, open label clinical trial that intends to treat 10 subjects with refractory ventricular tachycardia with the CyberHeart system using standard radiosurgical techniques. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyberHeart SystemThe CyberHeart system uses proprietary software to assist the cardiologist to contour ablation targets. Standard radiosurgical techniques are then used to accomplish ablation | Device | Open label |
Primary outcome
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.
4 secondary outcomes
Number of participants with a change in SF-36 Medical Outcomes Health Survey, as compared to pre-treatment questionaire responses
Time frame: 12 months
Number of defibrillation shocks as compared to pretreatment occurrence
Time frame: 12 months
Ventricular arrhythmia episodes, as compared to pretreatment occurrence
Time frame: 12 months
Left ventricular function post treatment
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Results publication: PubMed 26082532Loo 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire McCann study director
Varian Medical Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CyberHeart System in people with Tachycardia, Ventricular, run by Varian, a Siemens Healthineers Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02661048, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.