Atrial FibrillationNCT06584370
Transatrial Pericardial Separation to Enhance Safety of Subxiphoid Pericardial Access for Left Atrial Appendage Ligation
A study testing Pericardial insufflation with carbon dioxide through a transatrial microcatheter in people with Atrial Fibrillation and Left Atrial Appendage Ligation, run by Henry Ford Health System at 1 site in United States.
Trial summary
We use a tiny catheter through the heart to separate the pericardium with gas. We expect this to improve the safety of the Lariat procedure. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation, Left Atrial Appendage Ligation, Pericardium
- What is being tested?
- Pericardial insufflation with carbon dioxide through a transatrial microcatheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Aug 2015
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing subxiphoid access to the "empty" pericardial space as part of a Lariat left atrial appendage exclusion procedure
- Age ≥ 21 years
Who cannot join
- Does not consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transatrial Pericardial Separation to Enhance the Safety of Subxiphoid Pericardial Access for Lariat Lariat Left Atrial Appendage Ligation
We use a tiny catheter through the heart to separate the pericardium with gas. We expect this to improve the safety of the Lariat procedure.
Read the detailed description
The Lariat suture device enables non-surgical exclusion of the left atrial appendage possibly to prevent thromboembolism and stroke in patients with atrial fibrillation. Subxiphoid needle access to the pericardium (a standard approach to enter the pericardial space surrounding the heart using a needle underneath the breastbone) during Lariat risks injury to the heart surface that requires surgical repair.
In this protocol the investigators propose test a new method to increase the safety of needle access to the pericardium. Before needle access, the investigators introduce a separate tiny catheter into the pericardium from inside the heart through a tiny hole. The investigators then inject gas to push the heart away from the pericardial needle. This reduces the risk of injuring the heart during the standard Lariat procedure.
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Ligation, Pericardium, Epicardial Mapping, Heart Atria, Cardiac Surgical Procedures
- Being tested
- Pericardial insufflation with carbon dioxide through a transatrial microcatheter
- Medical subject headings
- Atrial Fibrillation, Pneumopericardium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericardial insufflation with carbon dioxide through a transatrial microcatheterProcedure or surgery
Separate the walls of the pericardium by insufflating the pericardial space with carbon dioide.
| Study group | Role | What they receive |
|---|---|---|
| Pericardial insufflation with CO2 | Experimental | Intentional transatrial introduction of a microcatheter to insufflate the pericardium with carbon dioxide, to separate the walls of the pericardium Receives: Procedure: Pericardial insufflation with carbon dioxide through a transatrial microcatheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful subxiphoid needle access without myocardial injury
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study startMay 2014
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Greenbaum, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584370
- Sponsor's protocol ID
- 8874
- Status last verified
- Aug 2024
- First submitted
- 29 Apr 2015
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Cohn WE, Winkler JA, Tuzun E, Hjelle A, Bassett K, Ahmad A, Frazier OH. Contrast pericardiography facilitates intrapericardial navigation under fluoroscopy. Ann Thorac Surg. 2010 Nov;90(5):1537-40. doi: 10.1016/j.athoracsur.2010.06.025.
PubMed 20971258Rogers T, Ratnayaka K, Schenke WH, Faranesh AZ, Mazal JR, O'Neill WW, Greenbaum AB, Lederman RJ. Intentional right atrial exit for microcatheter infusion of pericardial carbon dioxide or iodinated contrast to facilitate sub-xiphoid access. Catheter Cardiovasc Interv. 2015 Aug;86(2):E111-8. doi: 10.1002/ccd.25698. Epub 2014 Oct 28.
PubMed 25315516
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transatrial Pericardial Separation to Enhance the Safety of Subxiphoid Pericardial Access for Lariat Lariat Left Atrial Appendage Ligation
- ClinicalTrials.gov ID
- NCT06584370
- Acronym / sponsor ID
- 8874
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Ligation, Pericardium, Epicardial Mapping, Heart Atria, Cardiac Surgical Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 4 Sep 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.
We use a tiny catheter through the heart to separate the pericardium with gas. We expect this to improve the safety of the Lariat procedure.
Detailed description
The Lariat suture device enables non-surgical exclusion of the left atrial appendage possibly to prevent thromboembolism and stroke in patients with atrial fibrillation. Subxiphoid needle access to the pericardium (a standard approach to enter the pericardial space surrounding the heart using a needle underneath the breastbone) during Lariat risks injury to the heart surface that requires surgical repair.
In this protocol the investigators propose test a new method to increase the safety of needle access to the pericardium. Before needle access, the investigators introduce a separate tiny catheter into the pericardium from inside the heart through a tiny hole. The investigators then inject gas to push the heart away from the pericardial needle. This reduces the risk of injuring the heart during the standard Lariat procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pericardial insufflation with CO2 | Experimental | Procedure: Pericardial insufflation with carbon dioxide through a transatrial microcatheterIntentional transatrial introduction of a microcatheter to insufflate the pericardium with carbon dioxide, to separate the walls of the pericardium |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing subxiphoid access to the "empty" pericardial space as part of a Lariat left atrial appendage exclusion procedure
- Age ≥ 21 years
Key exclusion criteria (1 listed)
- Does not consent to participate
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 |
|---|---|---|
| Pericardial insufflation with carbon dioxide through a transatrial microcatheterSeparate the walls of the pericardium by insufflating the pericardial space with carbon dioide. | Procedure or surgery | Pericardial insufflation with CO2 |
Primary outcome
Successful subxiphoid needle access without myocardial injury
Time frame: Immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Background: PubMed 20971258Cohn WE, Winkler JA, Tuzun E, Hjelle A, Bassett K, Ahmad A, Frazier OH. Contrast pericardiography facilitates intrapericardial navigation under fluoroscopy. Ann Thorac Surg. 2010 Nov;90(5):1537-40. doi: 10.1016/j.athoracsur.2010.06.025.
- Results publication: PubMed 25315516Rogers T, Ratnayaka K, Schenke WH, Faranesh AZ, Mazal JR, O'Neill WW, Greenbaum AB, Lederman RJ. Intentional right atrial exit for microcatheter infusion of pericardial carbon dioxide or iodinated contrast to facilitate sub-xiphoid access. Catheter Cardiovasc Interv. 2015 Aug;86(2):E111-8. doi: 10.1002/ccd.25698. Epub 2014 Oct 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pericardial insufflation with carbon dioxide through a transatrial microcatheter in people with Atrial Fibrillation and Left Atrial Appendage Ligation, run by Henry Ford Health System at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 4 Sep 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful subxiphoid needle access without myocardial injury (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06584370, which also lists 2 linked publications.
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 4 Sep 2024.