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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Rook Epicardial Access Kit
DeviceAccess the epicardial surface of the heart via a subxiphoid approach with the subject device to facilitate guidewire placement into the pericardium.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Single ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Successful Epicardial Access
The number and percentage of patients in which successful epicardial access is achieved
Time frame
During procedure.Secondary outcomes
1
Speed of Access
The time from skin incision to confirmed guidewire access to the pericardial space
Time frame
During procedure.2
Rate of Use Errors
Recording any use errors that may occur in the clinical environment that have not been otherwise been observed.
Time frame
During procedure.Other outcomes
1
Rate of Adverse Events
The rate of occurrence of adverse events that have been determined to be related to the device by the clinical events committee
Time frame
Patients are monitored for adverse events until hospital discharge or up to 4 day after procedure.Sponsors and contacts
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Source ClinicalTrials.gov