Stroke, IschemicAPPEND-CTNCT06213285
APPEND-CT Registry
An observational study of Stroke, Ischemic and Device Related Thrombosis, run by Aarhus University Hospital at 2 sites in 2 countries.
Trial summary
The APPEND-CT registry is an investigator-driven multicenter retrospective observational database intended to compile cardiac CT follow-up data after Watchman FLX device implantation and function as a platform for answering clinical and research questions within LAAC follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Device Related Thrombosis, Atrial Fibrillation
- What is being tested?
- Watchman FLX left atrial appendage occlusion
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Feb 2024to Jan 2025
- 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: Watchman FLX implanted patients with a minimum of one early follow-up cardiac CT.
Who may be able to join
- Watchman FLX LAAO
- A minimum of one follow-up cardiac CT performed within 30-120 days post-procedure.
- A minimum of one year clinical follow-up data
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Cardiac Computed Tomography Following Watchman FLX Left Atrial APPENDage Closure
The APPEND-CT registry is an investigator-driven multicenter retrospective observational database intended to compile cardiac CT follow-up data after Watchman FLX device implantation and function as a platform for answering clinical and research questions within LAAC follow-up. The derived studies should support therapeutic decision-making, improve risk-stratification in LAAC and help generate hypotheses for potential future clinical intervention trials.
Read the detailed description
An investigator-driven multicenter retrospective observational database enrolling patients from high-volume North American and European centers. The database will include Watchman FLX implanted patients with a minimum of one follow-up cardiac CT performed within 45-120 days post-procedure. Additional timepoints may be entered. Cardiac CT scans are to be uploaded and will be analyzed by the core-lab at Aarhus University Hospital.
Investigator-reported findings will be systematically reported to the database. This includes information on baseline characteristics, preprocedural planning, implantation details, discharge medication, follow-up imaging and clinical endpoints of interest.
As a minimum, investigator-reported endpoints will be collected from patient registries at one-year follow-up by site-investigators. Endpoints of interest include ischemic stroke, systemic embolism, major bleeding, mortality, device-related thrombosis, pericardial effusion, vascular complications, and device migration.
- Being tested
- Watchman FLX left atrial appendage occlusion
- Keywords
- Left Atrial Appendage Occlusion, Cardiac Computed Tomography, Watchman FLX
- Medical subject headings
- Ischemic Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watchman FLX left atrial appendage occlusionDevice
Also called left atrial appendage closure, LAAO, LAAC
Early (30-120 days) CT follow-up after Watchman FLX LAAO
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic stroke
Clinically affirmed ischemic stroke
Measured: Minimum 12 months
Secondary outcomes (3)
Device-related thrombosis
High-grade hypoattenuated thickening as seen on cardiac CT
Measured: Minimum 12 months
Major bleeding
BARC >=2
Measured: Minimum 12 months
All-cause and cardiovascular mortality
As defined in the Munich consensus
Measured: Minimum 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start14 Feb 2024
- Primary completionAug 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, Boston Scientific Corporation
- Responsible party
- Principal investigator, Anders Kramer, Aarhus University Hospital
- Investigators
- Anders Kramer, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213285
- Sponsor's protocol ID
- ISRCAR00442
- Acronym
- APPEND-CT
- Status last verified
- May 2024
- First submitted
- 9 Jan 2024
- Last updated
- 30 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Patient data will be registered under a pseudonymous registry-ID and will not be personally identifiable.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Computed Tomography Following Watchman FLX Left Atrial APPENDage Closure
- ClinicalTrials.gov ID
- NCT06213285
- Acronym / sponsor ID
- APPEND-CT / ISRCAR00442
- Keywords
- Left Atrial Appendage Occlusion, Cardiac Computed Tomography, Watchman FLX
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Mayo Clinic, Boston Scientific Corporation
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 19 Jan 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 APPEND-CT registry is an investigator-driven multicenter retrospective observational database intended to compile cardiac CT follow-up data after Watchman FLX device implantation and function as a platform for answering clinical and research questions within LAAC follow-up. The derived studies should support therapeutic decision-making, improve risk-stratification in LAAC and help generate hypotheses for potential future clinical intervention trials.
Detailed description
An investigator-driven multicenter retrospective observational database enrolling patients from high-volume North American and European centers. The database will include Watchman FLX implanted patients with a minimum of one follow-up cardiac CT performed within 45-120 days post-procedure. Additional timepoints may be entered. Cardiac CT scans are to be uploaded and will be analyzed by the core-lab at Aarhus University Hospital.
Investigator-reported findings will be systematically reported to the database. This includes information on baseline characteristics, preprocedural planning, implantation details, discharge medication, follow-up imaging and clinical endpoints of interest.
As a minimum, investigator-reported endpoints will be collected from patient registries at one-year follow-up by site-investigators. Endpoints of interest include ischemic stroke, systemic embolism, major bleeding, mortality, device-related thrombosis, pericardial effusion, vascular complications, and device migration.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Watchman FLX implanted patients with a minimum of one early follow-up cardiac CT.
Key inclusion criteria (3 listed)
- Watchman FLX LAAO
- A minimum of one follow-up cardiac CT performed within 30-120 days post-procedure.
- A minimum of one year clinical follow-up data
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Watchman FLX left atrial appendage occlusionAlso: left atrial appendage closure, LAAO, LAACEarly (30-120 days) CT follow-up after Watchman FLX LAAO | Device | – |
Primary outcome
Ischemic stroke
Time frame: Minimum 12 months
Clinically affirmed ischemic stroke
3 secondary outcomes
Device-related thrombosis
Time frame: Minimum 12 months
Major bleeding
Time frame: Minimum 12 months
All-cause and cardiovascular mortality
Time frame: Minimum 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No. Patient data will be registered under a pseudonymous registry-ID and will not be personally identifiable.
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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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic and Device Related Thrombosis, run by Aarhus University Hospital at 2 sites in 2 countries.
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 3 inclusion and 0 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 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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?
Ischemic stroke (time frame: Minimum 12 months). 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 30 May 2024.