Epicardial Access Study With Rook
ConditionArrythmia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCirca Scientific, Inc.
About this trial
The goal of this clinical trial is to test how how effective the Circa Scientific Rook® Epicardial Access Kit is at gaining guidewire access to the outside surface of the heart (epicardium). In addition the safety of the device will be compared to the available data for alternative methods of epicardial access.
Participants will receive treatment with the subject device during the course of a typical epicardial electrophysiology procedure.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Rook Epicardial Access Kit
Treatment groups
40 Participants
are divided into 1 treatment groupLocations
1Na Homolce Hospital15030, Prague Czechia
Sponsors and collaborators
Circa Scientific, Inc.
Lead sponsor
Source ClinicalTrials.gov