Back to resultsCyberHeart's Cardiac Arrhythmia Ablation Treatment: Patients With Refractory Ventricular Tachycardia/Fibrillation
Primary Purpose
Tachycardia, Ventricular
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CyberHeart System
Sponsored by
About this trial
This is an interventional treatment trial for Tachycardia, Ventricular
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Texas Cardiac Arrhythmia Research Foundation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open label
Arm Description
Non-randomized, open label clinical trial that intends to treat 10 subjects with refractory ventricular tachycardia with the CyberHeart system using standard radiosurgical techniques.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Number of defibrillation shocks as compared to pretreatment occurrence
Defibrillation shocks will be recorded pre-treatment and post treatment at each follow-up visit.
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.
Left ventricular function post treatment
Left ventricular systolic and diastolic function will be assessed by echocardiography pre- and post treatment
Full Information
NCT ID
NCT02661048
First Posted
December 22, 2015
Last Updated
September 6, 2023
Sponsor
Varian, a Siemens Healthineers Company
1. Study Identification
Unique Protocol Identification Number
NCT02661048
Brief Title
CyberHeart's Cardiac Arrhythmia Ablation Treatment: Patients With Refractory Ventricular Tachycardia/Fibrillation
Official Title
CyberHeart's Cardiac Arrhythmia Ablation Treatment: Patients With Refractory Ventricular Tachycardia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 27, 2015 (Actual)
Primary Completion Date
July 6, 2023 (Actual)
Study Completion Date
July 6, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Varian, a Siemens Healthineers Company
4. Oversight
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachycardia, Ventricular
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open label
Arm Type
Experimental
Arm Description
Non-randomized, open label clinical trial that intends to treat 10 subjects with refractory ventricular tachycardia with the CyberHeart system using standard radiosurgical techniques.
Intervention Type
Device
Intervention Name(s)
CyberHeart System
Intervention Description
The CyberHeart system uses proprietary software to assist the cardiologist to contour ablation targets. Standard radiosurgical techniques are then used to accomplish ablation
Primary Outcome Measure Information:
Title
Outcome 1 is the Number of participants with Treatment related Serious Adverse Events as assessed by CTCAE v. 4.0
Description
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.
Time Frame
12 months (360 days) with Outcome assesment in first 30 days adn in days 31 to 1 year post treatment.
Secondary Outcome Measure Information:
Title
Number of participants with a change in SF-36 Medical Outcomes Health Survey, as compared to pre-treatment questionaire responses
Description
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
Time Frame
12 months
Title
Number of defibrillation shocks as compared to pretreatment occurrence
Description
Defibrillation shocks will be recorded pre-treatment and post treatment at each follow-up visit.
Time Frame
12 months
Title
Ventricular arrhythmia episodes, as compared to pretreatment occurrence
Description
The number of ventricular tachycardia episodes that required either anti-tachycardia pacing, or that self-terminated, will be recorded pre- and post treatment.
Time Frame
12 months
Title
Left ventricular function post treatment
Description
Left ventricular systolic and diastolic function will be assessed by echocardiography pre- and post treatment
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire McCann
Organizational Affiliation
Varian Medical Systems
Official's Role
Study Director
Facility Information:
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26082532
Citation
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.
Results Reference
result
Learn more about this trial
CyberHeart's Cardiac Arrhythmia Ablation Treatment: Patients With Refractory Ventricular Tachycardia/Fibrillation
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