Atrial FibrillationNCT05263024
Study on the Significance of Auricular Clip in Prevention and Treatment of Valvular Heart Disease Atrial Thrombosis
An observational study of Atrial Fibrillation and Thrombus; Embolism, run by Second Affiliated Hospital of Nanchang University.
Trial summary
To evaluate the safety and clinical efficacy of left atrial appendage in the prevention of thrombus in patients with valvular heart disease, to improve the product according to clinical conditions, to achieve clinically accurate treatment, and to establish the heart valve, the usefulness and universality of Warfarin's… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Thrombus; Embolism, Warfarin
- What is being tested?
- atrial appendage clip
- Type of treatment
- Medical device
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- 21 Feb 2022to 22 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring heart valve surgery with atrial fibrillation
Who may be able to join
- Patients with valvular heart disease aged between 18 and 75
- Valvular heart disease [Cardiovascular Surgery Volume, Clinical Diagnosis and Treatment Guidelines, Chinese Medical Association (2011 edition)]
- Preoperative cardiac function grade II-III (NYHA), no operation-related contraindications
- Understand the nature of this study, agree to participate in all terms of this study, sign informed consent, agree to accept postoperative treatment plan and follow-up requirements, and cooperate to complete follow-up
Who cannot join
- Patients whose left atrial appendage has been resected or occluded
- She had a history of open heart surgery with extensive adhesion of the pericardium
- Patients cannot be returned due to other reasons
- Failed to reach the end point in clinical trials of other drugs or devices
- X-ray is contraindicated or not suitable for TEE examination
- Those who are considered unsuitable for the clinical trial by the investigator
About this study
Official title: Study on the Significance of Auricular Clip in Prevention and Treatment of Valvular Heart Disease Atrial Thrombosis and the Related Precision Treatment Technique
To evaluate the safety and clinical efficacy of left atrial appendage in the prevention of thrombus in patients with valvular heart disease, to improve the product according to clinical conditions, to achieve clinically accurate treatment, and to establish the heart valve, the usefulness and universality of Warfarin's anticoagulant model were verified by the specimen library
Read the detailed description
Atrial fibrillation (AF) is a common arrhythmia. The risk of ischemic stroke in AF patients is 4-5 times higher than that in non-af patients, and leads to nearly 20% mortality and nearly 60% disability. Atrial fibrillation is associated with valvular disease and atrial fibrillation in about 30-70% of patients with valvular heart disease. Left atrial thrombus occurs in 15-25% of patients with atrial fibrillation. More than 90% of patients with atrial thrombus is located in the left atrial appendage. In patients with valvular atrial fibrillation, the left atrial appendage is clamped at the same time of valvular surgery to avoid recurrence of atrial thrombus-related stroke. In this clinical trial, the left atrial appendage was used to clamp the prethrombotic site of the heart to prevent stroke and improve the prognosis.
- Conditions
- Atrial Fibrillation, Thrombus; Embolism, Warfarin, Atrial Appendage, Surgery
- Being tested
- atrial appendage clip
- Medical subject headings
- Atrial Fibrillation, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atrial appendage clipDevice
During cardiac surgery, atrial fibrillation patients were treated with atrial appendage clipping
| Study group | Role | What they receive |
|---|---|---|
| left atrial appendage clip | Cardiac valvular patients complicated with atrial fibrillation need cardiac valvular surgery, according to the patient's wishes, cardiac auricular clamp at the same time Receives: Device: atrial appendage clip | |
| Left atrial appendage treated with conventional methods | Valvular heart disease with atrial fibrillation requires valvular heart surgery and left atrial ligation Receives: Device: atrial appendage clip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of auricular clip clipping
Success rate of auricular clip clipping
Measured: 12 months
Clinical success rate of auricular clip
Rate of patients without ischemic stroke, TIA, or systemic embolism 12 months after cardiac and auricular clipping
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start21 Feb 2022 (estimated)
- Primary completion22 Mar 2025 (estimated)
- Study completion22 Mar 2027 (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.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263024
- Sponsor's protocol ID
- 2021-53-TYH
- Status last verified
- Feb 2022
- First submitted
- 20 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Significance of Auricular Clip in Prevention and Treatment of Valvular Heart Disease Atrial Thrombosis and the Related Precision Treatment Technique
- ClinicalTrials.gov ID
- NCT05263024
- Acronym / sponsor ID
- 2021-53-TYH
- Conditions
- Atrial Fibrillation, Thrombus; Embolism, Warfarin, Atrial Appendage, Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 21 Feb 2022 (estimated)
- Primary completion
- 22 Mar 2025 (estimated)
- Study completion
- 22 Mar 2027 (estimated)
- First posted
- 2 Mar 2022 (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.
To evaluate the safety and clinical efficacy of left atrial appendage in the prevention of thrombus in patients with valvular heart disease, to improve the product according to clinical conditions, to achieve clinically accurate treatment, and to establish the heart valve, the usefulness and universality of Warfarin's anticoagulant model were verified by the specimen library
Detailed description
Atrial fibrillation (AF) is a common arrhythmia. The risk of ischemic stroke in AF patients is 4-5 times higher than that in non-af patients, and leads to nearly 20% mortality and nearly 60% disability. Atrial fibrillation is associated with valvular disease and atrial fibrillation in about 30-70% of patients with valvular heart disease. Left atrial thrombus occurs in 15-25% of patients with atrial fibrillation. More than 90% of patients with atrial thrombus is located in the left atrial appendage. In patients with valvular atrial fibrillation, the left atrial appendage is clamped at the same time of valvular surgery to avoid recurrence of atrial thrombus-related stroke. In this clinical trial, the left atrial appendage was used to clamp the prethrombotic site of the heart to prevent stroke and improve the prognosis.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| left atrial appendage clip | – | Device: atrial appendage clipCardiac valvular patients complicated with atrial fibrillation need cardiac valvular surgery, according to the patient's wishes, cardiac auricular clamp at the same time |
| Left atrial appendage treated with conventional methods | – | Device: atrial appendage clipValvular heart disease with atrial fibrillation requires valvular heart surgery and left atrial ligation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring heart valve surgery with atrial fibrillation
Key inclusion criteria (4 listed)
- Patients with valvular heart disease aged between 18 and 75
- Valvular heart disease [Cardiovascular Surgery Volume, Clinical Diagnosis and Treatment Guidelines, Chinese Medical Association (2011 edition)]
- Preoperative cardiac function grade II-III (NYHA), no operation-related contraindications
- Understand the nature of this study, agree to participate in all terms of this study, sign informed consent, agree to accept postoperative treatment plan and follow-up requirements, and cooperate to complete follow-up
Key exclusion criteria (6 listed)
- Patients whose left atrial appendage has been resected or occluded
- She had a history of open heart surgery with extensive adhesion of the pericardium
- Patients cannot be returned due to other reasons
- Failed to reach the end point in clinical trials of other drugs or devices
- X-ray is contraindicated or not suitable for TEE examination
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 |
|---|---|---|
| atrial appendage clipDuring cardiac surgery, atrial fibrillation patients were treated with atrial appendage clipping | Device | Left atrial appendage treated with conventional methods, left atrial appendage clip |
Primary outcome
Success rate of auricular clip clipping
Time frame: 12 months
Success rate of auricular clip clipping
Clinical success rate of auricular clip
Time frame: 12 months
Rate of patients without ischemic stroke, TIA, or systemic embolism 12 months after cardiac and auricular clipping
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Thrombus; Embolism, run by Second Affiliated Hospital of Nanchang University.
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 6 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: opening soon, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Success rate of auricular clip clipping (time frame: 12 months). The study lists 2 primary outcomes in all. 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 2 Mar 2022.