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NCT02661048 · ClinicalTrials.gov registry record · NA
CyberHeart's Cardiac Arrhythmia Ablation Treatment: Patients With Refractory Ventricular Tachycardia/Fibrillation
A NA study of Tachycardia, Ventricular, sponsored by Varian, a Siemens Healthineers Company.
- Completed
- Registry status
- NA
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT02661048: Completed NA study of Tachycardia, Ventricular, sponsored by Varian, a Siemens Healthineers Company.
NCT02661048 is a NA study of Tachycardia, Ventricular that has completed, run by Varian, a Siemens Healthineers Company. The registered enrollment target is 5 participants, below the 300-participant average among 4 other Tachycardia, Ventricular trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02661048, a NA study of Tachycardia, Ventricular, has completed, sponsored by Varian, a Siemens Healthineers Company.
- COMPLETED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE CyberHeart System
Study Locations (1)
Texas
- Texas Cardiac Arrhythmia Research Foundation - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2015-02-27 |
| Est. Completion | 2023-07-06 |
| Phase | NA |
What the finished NCT02661048 record still lists
NCT02661048 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 300-participant average among 4 other Tachycardia, Ventricular trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Tachycardia, Ventricular appearing as the primary indexed condition, and to 1 intervention - of which CyberHeart System is the first listed.
NCT02661048 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02661048 about?
NCT02661048 is a clinical study titled "CyberHeart's Cardiac Arrhythmia Ablation Treatment: Patients With Refractory Ventricular Tachycardia/Fibrillation". 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 ...
What is the current status of trial NCT02661048?
This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2015-02-27. Estimated completion is 2023-07-06.
What conditions does trial NCT02661048 study?
This clinical trial studies the following conditions: Tachycardia, Ventricular.
What interventions are being tested in trial NCT02661048?
The interventions under investigation include: CyberHeart System (DEVICE).
Who is sponsoring clinical trial NCT02661048?
This trial is sponsored by Varian, a Siemens Healthineers Company, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02661048 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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