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

NCT06455644 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2024-06-12

No results posted yet for this study

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. 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.

Conditions

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.

Sponsors & Collaborators

  • First Affiliated Hospital of Shantou University Medical College

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2026-10-31
Completion
2031-07-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06455644 on ClinicalTrials.gov