Status:
COMPLETED
Rook Epicardial Access Device Study
Lead Sponsor:
Talon Surgical
Conditions:
Ventricular Tachycardia
Arrythmia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to confirm the efficacy and safety of the Talon Surgical Rook® Epicardial Access Kit as a pericardial access device. The Rook® Epicardial Access Kit will be used to gain a...
Detailed Description
This is a first-in-human, prospective, non-randomized, single arm study to confirm the efficacy and safety of the Talon Surgical Rook® Epicardial Access Kit to achieve guidewire access to the pericard...
Eligibility Criteria
Inclusion
- Patient is clinically indicated to undergo a procedure that requires percutaneous access to the normal, non-distended, pericardial space.
- Patient is willing and able to provide written informed consent.
Exclusion
- Subject is younger than 18 years of age
- Previous cardiac surgery
- Myocardial infarction within 4 weeks prior to procedure
- Class IV NYHA (New York Heart Association) heart failure symptoms
- Subject with an active systemic infection
- Known carotid artery stenosis greater than 80%
- Presence of thrombus in the left atrium
- Congenital absence of a pericardium
- Coagulopathy
- Hemodynamic Instability
- Acute conditions (i.e. electrolyte abnormality, acute ischemia, drug toxicity)
- Severe hepatic dysfunction or enlargement
- Subject has Body Mass Index \> 40
- Life expectancy less than 6 months
- Subject is pregnant
- Subject is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
- Subject has known or suspected allergy to contrast media
Key Trial Info
Start Date :
January 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2019
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03427333
Start Date
January 18 2018
End Date
February 25 2019
Last Update
March 29 2019
Active Locations (1)
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1
Na Homolce Hospital
Prague, Czechia