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
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