NCT06455644Recruiting
Accuracy of LAA Occluder Size Selection: CT vs. DSA During Combined AF Ablation and LAA Occlusion
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
Source: ClinicalTrials.gov · Last updated 12 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 238 (estimated)
- First submitted
- 4 Jun 2024
- Start date
- Jul 2024
- Primary completion date
- Oct 2026
- Lead sponsor
- First Affiliated Hospital of Shantou University Medical College
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT06455644
What you commit to
- Study type: Interventional
- Planned participants: 238
- From Jul 2024 to the primary completion date, Oct 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 illness
- Allergy to contrast agents or other conditions that preclude cardiac CT or DSA imaging;
- Other conditions that the investigator deems make the participant unsuitable for this study.
Age
- Female patients of childbearing age planning to become pregnant during the follow-up period required by this study;
Other
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second People's Hospital of Foshan Coordinator of this site? Confirm its status | Foshan | China | Not yet recruiting |
| Foshan Nanhai District People's Hospital Coordinator of this site? Confirm its status | Foshan | China | Not yet recruiting |
| Meizhou Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Meizhou | China | Not yet recruiting |
| First Affiliated Hospital of Shantou University Medical College. Coordinator of this site? Confirm its status | Shantou | China | Recruiting |
| Guangdong Provincial Zhongshan Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Zhongshan | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.