Share this page:

CyberHeart’s cardiac arrhythmia ablation treatment: Patients with Refractory Ventricular Tachycardia / Fibrillation

Study Type/Phase: Pilot
Status: Not Recruiting

Ventricular Tachycardia (VT) is a pathological cardiac rhythm originating independently within the ventricles (primary pumping chambers) of the heart. VT can cause significant mortality and morbidity (side effects) by directly causing death or inducing syncope (lightheadedness), pulmonary edema (fluid in lungs), palpitations (rapid irregular heartbeats), and significant distress via recurrent discharges in those with implantable cardioverter defibrillators(ICDs).

Currently, there are several options for preventing and terminating VT. The options include pharmacological (prescription drug) therapy, electrical cardioversion (ICD), and catheter ablation (CA), all of which have side effects. CyberHeart, Inc. has developed a noninvasive (staying outside the body) software technology, called CardioPlan™, to utilize a radiosurgery platform to minimally ablate (scar, destroy) cardiac tissue that is causing a very fast heart beat (VT).

The objective of this clinical investigation is to evaluate the safety and efficacy of the CyberHeart System utilizing the already approved CyberKnife® machine, in patients with refractory (therapy resistant) ventricular tachycardia who have no viable options left.

The CyberKnife is a frameless robotic system that is used for delivering external x-ray beams in a process called stereotactic radiotherapy. This type of procedure uses precisely focused radiation beams to treat tumors and other problems in various parts of the body. In this study, radiotherapy will be delivered to the abnormal pathways in the heart using the CyberKnife system. We will investigate whether this approach is a viable alternative for abnormal heart rhythms.

Up to 5 patients will be enrolled at El Camino Hospital Mountain View location.

Speak with your doctor to determine whether you meet the following criteria for participation in this study.

Inclusion Criteria Exclusion Criteria
  • Signed Informed Consent and Able and willing to comply with all pre-, post-, and follow-up testing required
  • 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% estimated by echocardiogram, ventriculography or radionuclide imaging within the previous 30 days.
  • Presence of structural heart disease, which can be defined as: decreased segmental ventricular wall motion, mild to moderate heart valve dysfunction, scar or fibrosis, most likely secondary to coronary artery disease or congenital heart disease associated with arrhythmia.
  • Failure of or ineligible for catheter ablation.
  • Failure of catheter ablation is defined as recurrence of symptomatic VT that induced at least one ICD shock following the last catheter ablation procedure. For patients with non-ischemic cardiomyopathy, both epicardial ablation and endocardial ablation should have been attempted before being called failures of catheter ablation. For patients with ischemic cardiomyopathy, both epicardial ablation and endocardial ablation should have been attempted at an academic medical center before being called failures of catheter ablation, unless, in the opinion of the referring electrophysiologist, and with the agreement of the independent Clinical Reviewer, such attempt is impossible and deemed to be futile. In essence, for both subgroups (i.e. patients with ischemic cardiomyopathy and those with non-ischemic cardiomyopathy), the use of an independent clinical reviewer* along with the opinion of the referring EP is warranted to ensure that the patients are left with no other viable options.
  • Conditions that will make a patient ineligible for catheter ablation are limited to the following:
    • Definite protruding LV thrombus on echocardiogram that in the opinion of the independent Clinical Reviewer* would preclude a VT catheter ablation procedure in this subject.
    • Contraindication to heparin that in the opinion of the independent Clinical Reviewer* would preclude a VT catheter ablation procedure in this subject.
    • Significant congenital anomaly or atherosclerotic arterial disease that in the opinion of the independent Clinical Reviewer* would preclude vascular access or catheter manipulation necessary for a VT catheter ablation procedure in this subject.
  • Failure of AAD therapy due to recurrence of symptomatic VT that induced at least one ICD shock. Patients should have failed or be unable to take further amiodarone or sotalol before being called failures of AAD therapy. Furthermore, patients should have failed or be intolerant to a combination of amiodarone and mexilitine before being called failures of AAD therapy because the combination is commonly used to control VT when amiodarone is failed. An exception may be made based on the review and determination of the Independent Clinical Reviewer*.
  • Definition of Independent Clinical Reviewer: A board certified Electrophysiologist who is not affiliated with the study sponsor CyberHeart or with the study but treats patients with VT and performs substrate ablation for ischemic and non-ischemic VTs.
  • 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 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

Principal Investigator

Daniel Kaiser, MD

Sponsor

Cyber Heart Inc.

NCT Number

NCT02661048

Contact

John Tejeda, Enterprise Senior Director for Clinical Research
650-691-4894
John_Tejeda@elcaminohealth.org

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.

 

You may also be interested in...

Visitor Screener

Visitor Restrictions

A visitor policy is in effect due to more restrictive measures being taken throughout the Bay Area.
HealthPerks Banner

Sign Up for HealthPerks

Get health information, event invitations, free screenings and more delivered to your inbox.
Find a doctor who will fit you well.

Find a Doctor

Use our directory to find a doctor with an office near our Mountain View or Los Gatos campus.