Epicardial Access Study With Rook
EASY-R
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 17, 2023
CompletedFirst Submitted
Initial submission to the registry
April 20, 2024
CompletedFirst Posted
Study publicly available on registry
April 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2024
CompletedAugust 21, 2024
August 1, 2024
10 months
April 20, 2024
August 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Successful Epicardial Access
The number and percentage of patients in which successful epicardial access is achieved
During procedure.
Secondary Outcomes (2)
Speed of Access
During procedure.
Rate of Use Errors
During procedure.
Other Outcomes (1)
Rate of Adverse Events
Patients are monitored for adverse events until hospital discharge or up to 4 day after procedure.
Study Arms (1)
Single Arm
EXPERIMENTALSingle arm of the study that receives treatment with the subject device.
Interventions
Access the epicardial surface of the heart via a subxiphoid approach with the subject device to facilitate guidewire placement into the pericardium.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Na Homolce Hospital
Prague, 15030, Czechia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Petr Neuzil, MD
Nemocnice Na Homolce
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2024
First Posted
April 29, 2024
Study Start
December 17, 2023
Primary Completion
October 15, 2024
Study Completion
October 15, 2024
Last Updated
August 21, 2024
Record last verified: 2024-08