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Recruiting NCT06455644

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

No phase Interventional Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CT group, DSA group.
Who it may be relevant to
Registry conditions: Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Other CT group
    After completing the AF ablation, select the appropriate LAA occluder based on preoperative CT measurements for implantation.
  • Other DSA group
    After completing the AF ablation, select the appropriate LAA occluder based on intraoperative DSA measurements for implantation.

Primary outcome measures

  • Accuracy of LAA occluder size selection [Time frame: During procedure]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 5 centers
  • Foshan Nanhai District People's Hospital — Foshan
  • The Second People's Hospital of Foshan — Foshan
  • Meizhou Hospital of Traditional Chinese Medicine — Meizhou
  • First Affiliated Hospital of Shantou University Medical College — Shantou
  • Guangdong Provincial Zhongshan Hospital of Traditional Chinese Medicine — Zhongshan

Identifiers

NCT: NCT06455644 · B-2024-091

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗