Atrial FibrillationNCT05011981
Hemostatic Activity Following LAAO
An observational study of Atrial Fibrillation and Stroke, run by University of Aarhus at 1 site in Denmark.
Trial summary
The primary objective of this study is to prospectively investigate hemostatic activity following transcatheter left atrial appendage occlusion (LAAO). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- Left Atrial Appendage Occlusion
- Type of treatment
- Medical device
- How many people
- 135 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Oct 2021to Dec 2024
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Only patients already eligible for LAAO will be screened by clinical personnel and potentially recruited for participation. Blood samples will be systematically sampled during planned follow-up timepoints.
Who may be able to join
- Age > 18 years
- Atrial fibrillation (paroxysmal, persistent, or permanent)
- Admitted and eligible for LAAO
- Signed written consent
Who cannot join
- Known hereditary bleeding disorders (i.e. Hemophilia A and B, Von Willebrand disease)
- Platelet count < 75 x 109/ml
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemostatic Activity Following Left Atrial Appendage Occlusion
The primary objective of this study is to prospectively investigate hemostatic activity following transcatheter left atrial appendage occlusion (LAAO).
Read the detailed description
This is a prospective cohort study of patients undergoing transcatheter LAAO at Aarhus University Hospital. Hemostatic consequences following device implantation will be evaluated using blood samples collected pre- and post-procedurally, and serially during three months follow-up in 135 LAAO patients. Platelet function and characteristics, overall activation of the extrinsic coagulation pathway and the intrinsic contact activation pathway, as well as endothelial response to implantation, will be assessed through a wide range of biochemical analyses. Patients will serve as their own controls, with a final control blood sample collected at three-months follow-up.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- Left Atrial Appendage Occlusion
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Atrial Appendage OcclusionDevice
Also called Left Atrial Appendage Closure
Interventional left atrial appendage occlusion with the Amulet or Watchman device
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in coagulation activity
Coagulation activity as measured by prothrombin fragment 1+2
Measured: 7 days, 14 days, 90 days
Secondary outcomes (6)
Change in platelet activity
Incl. platelet count, turnover, and aggregation
Measured: 7 days, 14 days, 90 days
Additional measures of changes in coagulation and contact activation
Incl. thrombin generation, fibrinogen, d-dimer and coagulation factors
Measured: 7 days, 14 days, 90 days
Change in endothelial activation and response
Incl. changes in soluble thrombomodulin, syndecan-1, selectin and von Willebrand factor
Measured: 7 days, 14 days, 90 days
Non-procedural bleeding events
As defined by the Bleeding Academic Research Consortium
Measured: 7 days, 14 days, 90 days
Radiographical evidence of device endothelization
On CT indicated by no contrast patency distal to the LAAO device.
Measured: 7 days, 14 days, 90 days
Radiographically confirmed device-related thrombosis
Defined as high grade HAT on follow-up cardiac CT or TEE
Measured: 7 days, 14 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start11 Oct 2021
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Anders Kramer, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011981
- Sponsor's protocol ID
- Hemo-LAAO
- Status last verified
- Jan 2024
- First submitted
- 12 Aug 2021
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemostatic Activity Following Left Atrial Appendage Occlusion
- ClinicalTrials.gov ID
- NCT05011981
- Acronym / sponsor ID
- Hemo-LAAO
- Conditions
- Atrial Fibrillation, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Aug 2021 (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 primary objective of this study is to prospectively investigate hemostatic activity following transcatheter left atrial appendage occlusion (LAAO).
Detailed description
This is a prospective cohort study of patients undergoing transcatheter LAAO at Aarhus University Hospital. Hemostatic consequences following device implantation will be evaluated using blood samples collected pre- and post-procedurally, and serially during three months follow-up in 135 LAAO patients. Platelet function and characteristics, overall activation of the extrinsic coagulation pathway and the intrinsic contact activation pathway, as well as endothelial response to implantation, will be assessed through a wide range of biochemical analyses. Patients will serve as their own controls, with a final control blood sample collected at three-months follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Only patients already eligible for LAAO will be screened by clinical personnel and potentially recruited for participation. Blood samples will be systematically sampled during planned follow-up timepoints.
Key inclusion criteria (4 listed)
- Age > 18 years
- Atrial fibrillation (paroxysmal, persistent, or permanent)
- Admitted and eligible for LAAO
- Signed written consent
Key exclusion criteria (2 listed)
- Known hereditary bleeding disorders (i.e. Hemophilia A and B, Von Willebrand disease)
- Platelet count < 75 x 109/ml
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 |
|---|---|---|
| Left Atrial Appendage OcclusionAlso: Left Atrial Appendage ClosureInterventional left atrial appendage occlusion with the Amulet or Watchman device | Device | – |
Primary outcome
Change in coagulation activity
Time frame: 7 days, 14 days, 90 days
Coagulation activity as measured by prothrombin fragment 1+2
6 secondary outcomes
Change in platelet activity
Time frame: 7 days, 14 days, 90 days
Additional measures of changes in coagulation and contact activation
Time frame: 7 days, 14 days, 90 days
Change in endothelial activation and response
Time frame: 7 days, 14 days, 90 days
Non-procedural bleeding events
Time frame: 7 days, 14 days, 90 days
Radiographical evidence of device endothelization
Time frame: 7 days, 14 days, 90 days
Radiographically confirmed device-related thrombosis
Time frame: 7 days, 14 days, 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 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.
Anders Kramer, MD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Stroke, run by University of Aarhus at 1 site in Denmark.
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 4 inclusion and 2 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 11 Jan 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 Denmark. 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?
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?
Change in coagulation activity (time frame: 7 days, 14 days, 90 days). 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 11 Jan 2024.