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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
Sponsor:
Information provided by (Responsible Party):
CyberHeart Inc.

Brief 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.


Condition or disease Intervention/treatment Phase
Tachycardia, Ventricular Device: CyberHeart System Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. Left ventricular function post treatment [ Time Frame: 12 months ]
    Left ventricular systolic and diastolic function will be assessed by echocardiography pre- and post treatment



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Patrick Maguire, MD PhD 650-962-4639 pmaguire@cyberheartinc.com
Contact: Edward Gardner, PhD 650-962-4639 edward_gardner_phd@sbcglobal.net

Locations
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United States, California
El Camino Hospital Recruiting
Mountain View, California, United States, 94040
Contact: Travis Stewart, BS    650-691-4896    travis_stewart@elcaminohospital.org   
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 <dscardinal@austinheartbeat.com>   
Principal Investigator: Amin Al-ahmad, MD         
Sponsors and Collaborators
CyberHeart Inc.
Investigators
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Study Director: Patrick Maguire, MD PhD CyberHeart Inc.

Publications:
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Responsible Party: CyberHeart Inc.
ClinicalTrials.gov Identifier: NCT02661048     History of Changes
Other Study ID Numbers: CyberHeart Inc. -001
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes