Atrial FibrillationNCT05086653
Complications From Left Atrial Appendage Occluder
An observational study of Atrial Fibrillation and Cardiac Perforation, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial summary
The following case reported a rare complication of left atrial appendage perforation complicated by cardiac tamponade during LAAO device deployment and its corresponding surgical management Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Atrial Fibrillation, Cardiac Perforation, Cardiac Tamponade
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Jun 2020to 25 Oct 2020
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: one female patient involved
Who may be able to join
- 73-year-old woman with CHA2DS2-VASc score 4
Who cannot join
- nil
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Surgery, Division of Cardiovascular Surgery
Kaohsiung City, 807
About this study
Official title: The Management of Left Atrial Appendage Perforation Complicated by Cardiac Tamponade During Left Atrial Appendage Occluder Device Deployment
The following case reported a rare complication of left atrial appendage perforation complicated by cardiac tamponade during LAAO device deployment and its corresponding surgical management
- Conditions
- Atrial Fibrillation, Cardiac Perforation, Cardiac Tamponade
- Being tested
- Surgery
- Medical subject headings
- Atrial Fibrillation, Cardiac Tamponade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Sutured by Prolene 3-0 with two layers of pledge
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment related adverse events
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start20 Jun 2020
- Primary completion20 Jul 2020
- Study completion25 Oct 2020
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siew Yoek Chan, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086653
- Sponsor's protocol ID
- LAA
- Status last verified
- Oct 2021
- First submitted
- 27 Sep 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a case report
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Management of Left Atrial Appendage Perforation Complicated by Cardiac Tamponade During Left Atrial Appendage Occluder Device Deployment
- ClinicalTrials.gov ID
- NCT05086653
- Acronym / sponsor ID
- LAA
- Conditions
- Atrial Fibrillation, Cardiac Perforation, Cardiac Tamponade
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 25 Oct 2020 (actual)
- First posted
- 21 Oct 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 following case reported a rare complication of left atrial appendage perforation complicated by cardiac tamponade during LAAO device deployment and its corresponding surgical management
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- one female patient involved
Key inclusion criteria (1 listed)
- 73-year-old woman with CHA2DS2-VASc score 4
Key exclusion criteria (1 listed)
- nil
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 |
|---|---|---|
| SurgerySutured by Prolene 3-0 with two layers of pledge | Procedure or surgery | – |
Primary outcome
Treatment related adverse events
Time frame: Three months
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 21 Oct 2021.
- Individual participant dataSharing planned: No. This is a case report
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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?
An observational study of Atrial Fibrillation and Cardiac Perforation, run by Kaohsiung Medical University at 1 site in Taiwan.
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 1 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 21 Oct 2021. 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 Taiwan. 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?
Treatment related adverse events (time frame: Three 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 21 Oct 2021; AzTrials last refreshed its copy on 26 Oct 2026.