ArrythmiaEASY-RNCT06388629
Epicardial Access Study With Rook
A study testing Rook Epicardial Access Kit in people with Arrythmia, run by Circa Scientific, Inc. at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrythmia
- What is being tested?
- Rook Epicardial Access Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- 17 Dec 2023to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%
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- 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
- Subject is known to have pericardial fibrosis, pericardial adhesions, or prior failed epicardial access
Trial locations and contacts
1 site in 1 country.
David Director of Product Development contact
Czechia1 site, 1 recruiting
- Recruiting
Na Homolce Hospital
Prague, 15030
Petr Neuzil, MD, PhD, +420257272211
About this study
Official title: Epicardial Access Study With Rook (EASY-R)
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.
Read the detailed description
This trial is a confirmatory trial for the Circa Scientific Rook® Epicardial Access Kit for accessing the epicardial surface of the heart via a subxiphoid approach to facilitate guidewire placement into the pericardial space in adult patients. The purpose of this study is to confirm the safety and establish the efficacy of the Circa Scientific Rook® Epicardial Access Kit as a pericardial access device. The Rook® Epicardial Access Kit will be used to gain access the epicardial surface of the heart via a subxiphoid approach in adult patients with a normal, non-distended pericardial space.
Access success of the test device to the pericardial space and occurrence of CEC-adjudicated device and procedure related adverse events will be assessed in relation to complication rate existing data from the literature presenting epicardial access procedure results during subxiphoid (minimally invasive) surgical procedures. This is a prospective, single-arm, non-randomized study.
The primary endpoint is successful pericardial access through the use of the Circa Scientific Rook® Epicardial Access Kit, achieving guidewire access to the pericardial space as confirmed during the procedure by standard x-ray technique. The safety endpoint is the occurrence of CEC-adjudicated device or procedure related adverse events through hospital discharge or up to 4 days post procedure, whichever comes first. Additional endpoints include speed of access, ease of use and human factors data.
- Conditions
- Arrythmia
- Being tested
- Rook Epicardial Access Kit
- Keywords
- Electrophysiology, Pericardial Access, Epicardial Access, EP
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rook Epicardial Access KitDevice
Access the epicardial surface of the heart via a subxiphoid approach with the subject device to facilitate guidewire placement into the pericardium.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Single arm of the study that receives treatment with the subject device. Receives: Device: Rook Epicardial Access Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Epicardial Access
The number and percentage of patients in which successful epicardial access is achieved
Measured: During procedure.
Secondary outcomes (2)
Speed of Access
The time from skin incision to confirmed guidewire access to the pericardial space
Measured: During procedure.
Rate of Use Errors
Recording any use errors that may occur in the clinical environment that have not been otherwise been observed.
Measured: During procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start17 Dec 2023
- Primary completion15 Oct 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-randomized
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Circa Scientific, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Petr Neuzil, MD, Principal investigator, Nemocnice Na Homolce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388629
- Sponsor's protocol ID
- M064-066 Rev 00
- Acronym
- EASY-R
- Status last verified
- Aug 2024
- First submitted
- 20 Apr 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epicardial Access Study With Rook (EASY-R)
- ClinicalTrials.gov ID
- NCT06388629
- Acronym / sponsor ID
- EASY-R / M064-066 Rev 00
- Conditions
- Arrythmia
- Keywords
- Electrophysiology, Pericardial Access, Epicardial Access, EP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Circa Scientific, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2023 (actual)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This trial is a confirmatory trial for the Circa Scientific Rook® Epicardial Access Kit for accessing the epicardial surface of the heart via a subxiphoid approach to facilitate guidewire placement into the pericardial space in adult patients. The purpose of this study is to confirm the safety and establish the efficacy of the Circa Scientific Rook® Epicardial Access Kit as a pericardial access device. The Rook® Epicardial Access Kit will be used to gain access the epicardial surface of the heart via a subxiphoid approach in adult patients with a normal, non-distended pericardial space.
Access success of the test device to the pericardial space and occurrence of CEC-adjudicated device and procedure related adverse events will be assessed in relation to complication rate existing data from the literature presenting epicardial access procedure results during subxiphoid (minimally invasive) surgical procedures. This is a prospective, single-arm, non-randomized study.
The primary endpoint is successful pericardial access through the use of the Circa Scientific Rook® Epicardial Access Kit, achieving guidewire access to the pericardial space as confirmed during the procedure by standard x-ray technique. The safety endpoint is the occurrence of CEC-adjudicated device or procedure related adverse events through hospital discharge or up to 4 days post procedure, whichever comes first. Additional endpoints include speed of access, ease of use and human factors data.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-randomized
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: Rook Epicardial Access KitSingle arm of the study that receives treatment with the subject device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rook Epicardial Access KitAccess the epicardial surface of the heart via a subxiphoid approach with the subject device to facilitate guidewire placement into the pericardium. | Device | Single Arm |
Primary outcome
Successful Epicardial Access
Time frame: During procedure.
The number and percentage of patients in which successful epicardial access is achieved
2 secondary outcomes
Speed of Access
Time frame: During procedure.
Rate of Use Errors
Time frame: During procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Director of Product Development contact
Petr Neuzil, MD principal investigator
Nemocnice Na Homolce
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rook Epicardial Access Kit in people with Arrythmia, run by Circa Scientific, Inc. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Director of Product Development ((303) 951-8767 ext. 201, david.willenbrink@circascientific.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Epicardial Access (time frame: During procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.