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NCT Number: NCT06455644

Accuracy of LAA Occluder Size Selection: CT vs. DSA During Combined AF Ablation and LAA Occlusion

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foshan Nanhai District People's Hospital, Foshan, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

CT group

Other

After completing the AF ablation, select the appropriate LAA occluder based on preoperative CT measurements for implantation.

DSA group

Other

After completing the AF ablation, select the appropriate LAA occluder based on intraoperative DSA measurements for implantation.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Procedure success

    Time frame: During procedure

    Technical success of the LAA occlusion procedure without serious procedure-related complications

  2. Peri-device leak at 3 months post-procedure

    Time frame: 3 months

    Proportion of peri-device leak at the occluder evaluated by TEE or CT

  3. Procedure-related times

    Time frame: During procedure

    Total procedure time, AF ablation time, and LAA occlusion time

  4. Incidence of major adverse events (MAE) related to the device or procedure within 3 months post-procedure

    Time frame: 3 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Zhongbo Xiao, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Shantou University Medical College

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2031
First posted
Jun 12, 2024
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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