CyberHeart's Cardiac Arrhythmia Ablation Treatment: Patients With Refractory Ventricular Tachycardia/Fibrillation

NCT02661048 | Completed DMC FDA Device

• 1 other identifier: CyberHeart Inc. -001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical investigation is to evaluate:

1. 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. 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.

Conditions

Tachycardia, Ventricular

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• Number of participants with a change in SF-36 Medical Outcomes Health Survey, as compared to pre-treatment questionaire responses

  12 months

• Number of defibrillation shocks as compared to pretreatment occurrence

  12 months

• Ventricular arrhythmia episodes, as compared to pretreatment occurrence

  12 months

• Left ventricular function post treatment

  12 months

Study Arms (1)

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.

Device: CyberHeart System

Interventions

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

Open label

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years of age or greater.
• Left ventricular ejection fraction ≥ 20%.
• Failure of or ineligible for catheter ablation.

You may not qualify if:

• 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

Sponsors & Collaborators

• Varian, a Siemens Healthineers Company: lead

Study Sites (1)

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Related Publications (1)

• 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.

  PMID: 26082532 RESULT

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Claire McCann

  Varian Medical Systems

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: January 21, 2016
• Study Start: February 27, 2015
• Primary Completion: July 6, 2023
• Study Completion: July 6, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

US (1)