Atrial FibrillationNCT06455644
Accuracy of LAA Occluder Size Selection: CT vs. DSA During Combined AF Ablation and LAA Occlusion
A study testing CT group and DSA group in people with Atrial Fibrillation and Arrhythmias, Cardiac, run by First Affiliated Hospital of Shantou University Medical College at 5 sites in China.
Trial summary
This study is a prospective, multi-center, randomized controlled trial. The subjects are patients scheduled to undergo a combined procedure of atrial fibrillation (AF) ablation and left atrial appendage (LAA) occlusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases
- What is being tested?
- CT group and DSA group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 5 sitesChina
- Study dates
- Jul 2024to Jul 2031
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Patients with non-valvular atrial fibrillation scheduled to undergo atrial fibrillation ablation and percutaneous left atrial appendage occlusion;
- Able to understand the purpose of the trial, willing to participate in the study, and the subject or their legal representative has signed the informed consent form, and is willing to complete the follow-up according to the protocol requirements.
Who cannot join
- Allergy to contrast agents or other conditions that preclude cardiac CT or DSA imaging;
- Absence of clear images for measuring the diameter of the LAA in all layers of the CT scan;
- Imaging indicates the presence of thrombus in the left atrium or LAA;
- Patients with valvular AF (mechanical valve replacement or moderate to severe mitral stenosis combined with AF);
- LAA depth < 15 mm, or LAA anchor zone diameter < 10 mm or > 33 mm;
- Female patients of childbearing age planning to become pregnant during the follow-up period required by this study;
- Currently participating in another clinical trial of drugs or medical devices and has not yet completed the primary endpoints of that study, which may confound the results of this study or affect the participant's compliance with the follow-up;
- Other conditions that the investigator deems make the participant unsuitable for this study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Zhongbo Xiao, MD contact
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
Foshan Nanhai District People's Hospital
Foshan, Guangdong
Bo Li, MD
- Not yet recruiting
The Second People's Hospital of Foshan
Foshan, Guangdong
Jianqiu Liang, MD
- Not yet recruiting
Meizhou Hospital of Traditional Chinese Medicine
Meizhou, Guangdong
Bo Zhang, MD
- Recruiting
First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong
Zhongbo Xiao, MD
- Not yet recruiting
Guangdong Provincial Zhongshan Hospital of Traditional Chinese Medicine
Zhongshan, Guangdong
Ziyang Hu, MD
About this study
Official title: The Accuracy of Left Atrial Appendage Occluder Size Selection Between Preoperative CT and Intraoperative DSA Evaluation During a Combined Atrial Fibrillation Ablation and Left Atrial Appendage Occlusion Procedure
This study is a prospective, multi-center, randomized controlled trial. The subjects are patients scheduled to undergo a combined procedure of atrial fibrillation (AF) ablation and left atrial appendage (LAA) occlusion. After signing the informed consent form, the subjects will be randomly assigned to either the cardiac Computed Tomography (CT) group or the Digital Subtraction Angiography (DSA) group. The operator will select the appropriate LAA occluder size for implantation based on different measurement methods. All subjects will undergo clinical follow-up before discharge and at 3 months postoperatively, as well as telephone follow-up 1-5 years after the surgery.
- Being tested
- CT group, DSA group
- Keywords
- Left atrial appendage closure, Atrial fibrillation, Pacifier-like occluder, Stroke prevention
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT groupOther
After completing the AF ablation, select the appropriate LAA occluder based on preoperative CT measurements for implantation.
DSA groupOther
After completing the AF ablation, select the appropriate LAA occluder based on intraoperative DSA measurements for implantation.
| Study group | Role | What they receive |
|---|---|---|
| CT group | Experimental | CT-Guided Size Selection for LAA Occluder Receives: Other: CT group |
| DSA group | Active comparator | DSA-Guided Size Selection for LAA Occluder Receives: Other: DSA group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of LAA occluder size selection
Accuracy is defined as: the occluder's anchor disc seats beyond the circumflex artery, the compression of the anchor disc after release is 3-6 mm, peri-device leak is ≤ 3 mm, and the occluder remains stable during the tug test.
Measured: During procedure
Secondary outcomes (4)
Procedure success
Technical success of the LAA occlusion procedure without serious procedure-related complications
Measured: During procedure
Peri-device leak at 3 months post-procedure
Proportion of peri-device leak at the occluder evaluated by TEE or CT
Measured: 3 months
Procedure-related times
Total procedure time, AF ablation time, and LAA occlusion time
Measured: During procedure
Incidence of major adverse events (MAE) related to the device or procedure within 3 months post-procedure
MAE is defined as unexplained death or any device or procedure-related complications, including but not limited to death, stroke, or transient ischemic attack (TIA), serious pericardial effusion/pericardial tamponade requiring pericardiocentesis or surgery, device embolization, life-threatening or severe bleeding events, and severe vascular access complications
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionJul 2031 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Shantou University Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongbo Xiao, First Affiliated Hospital of Shantou University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455644
- Sponsor's protocol ID
- B-2024-091
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Left Atrial Appendage Occluder Size Selection Between Preoperative CT and Intraoperative DSA Evaluation During a Combined Atrial Fibrillation Ablation and Left Atrial Appendage Occlusion Procedure
- ClinicalTrials.gov ID
- NCT06455644
- Acronym / sponsor ID
- B-2024-091
- Keywords
- Left atrial appendage closure, Atrial fibrillation, Pacifier-like occluder, Stroke prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Shantou University Medical CollegeUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 12 Jun 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.
This study is a prospective, multi-center, randomized controlled trial. The subjects are patients scheduled to undergo a combined procedure of atrial fibrillation (AF) ablation and left atrial appendage (LAA) occlusion. After signing the informed consent form, the subjects will be randomly assigned to either the cardiac Computed Tomography (CT) group or the Digital Subtraction Angiography (DSA) group. The operator will select the appropriate LAA occluder size for implantation based on different measurement methods. All subjects will undergo clinical follow-up before discharge and at 3 months postoperatively, as well as telephone follow-up 1-5 years after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT group | Experimental | Other: CT groupCT-Guided Size Selection for LAA Occluder |
| DSA group | Active comparator | Other: DSA groupDSA-Guided Size Selection for LAA Occluder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- Patients with non-valvular atrial fibrillation scheduled to undergo atrial fibrillation ablation and percutaneous left atrial appendage occlusion;
- Able to understand the purpose of the trial, willing to participate in the study, and the subject or their legal representative has signed the informed consent form, and is willing to complete the follow-up according to the protocol requirements.
Key exclusion criteria (8 listed)
- Allergy to contrast agents or other conditions that preclude cardiac CT or DSA imaging;
- Absence of clear images for measuring the diameter of the LAA in all layers of the CT scan;
- Imaging indicates the presence of thrombus in the left atrium or LAA;
- Patients with valvular AF (mechanical valve replacement or moderate to severe mitral stenosis combined with AF);
- LAA depth < 15 mm, or LAA anchor zone diameter < 10 mm or > 33 mm;
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 |
|---|---|---|
| CT groupAfter completing the AF ablation, select the appropriate LAA occluder based on preoperative CT measurements for implantation. | Other | CT group |
| DSA groupAfter completing the AF ablation, select the appropriate LAA occluder based on intraoperative DSA measurements for implantation. | Other | DSA group |
Primary outcome
Accuracy of LAA occluder size selection
Time frame: During procedure
Accuracy is defined as: the occluder's anchor disc seats beyond the circumflex artery, the compression of the anchor disc after release is 3-6 mm, peri-device leak is ≤ 3 mm, and the occluder remains stable during the tug test.
4 secondary outcomes
Procedure success
Time frame: During procedure
Peri-device leak at 3 months post-procedure
Time frame: 3 months
Procedure-related times
Time frame: During procedure
Incidence of major adverse events (MAE) related to the device or procedure within 3 months post-procedure
Time frame: 3 months
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 12 Jun 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.
Zhongbo Xiao, MD contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT group and DSA group in people with Atrial Fibrillation and Arrhythmias, Cardiac, run by First Affiliated Hospital of Shantou University Medical College at 5 sites in China.
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 8 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: looking for participants now, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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?
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?
Contact Zhongbo Xiao, MD (307523577@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of LAA occluder size selection (time frame: During procedure). 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 12 Jun 2024; AzTrials last refreshed its copy on 26 Oct 2026.