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A Novel Echocardiography-Guided Strategy for Percutateous Closure of Atrial Septal Defect Assisted by PannaWire

Study acronym: PANNA-ASD
StatusNot Yet Recruiting
PhasePhase 4
Started
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Record History

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  1. Notable Start date: Jul 1, 2025 to Mar 14, 2026v2 Show 4 more changesShow less
    • Eligibility criteria expanded, about 107 words
    • Secondary endpoints: details revised at 1 of 6 entries
    • Study arms: 2 to 3
    • Study title shortened, about 2 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Atrial septal defect (ASD) is a common congenital heart disease, and percutaneous interventional therapy is the main and effective treatment. Traditional percutaneous closure procedures are performed under fluoroscopic guidance and require contrast agents. A retrospective analysis of over 20,000 adult patients with congenital heart disease revealed that even low-dose radiation exposure was significantly associated with an increased long-term risk of malignancy. Moreover, the use of contrast agents carries the risk of allergic reactions and kidney injury. Radiation and contrast agents not only pose iatrogenic harm to patients but also limit the use of interventional techniques in special populations, such as pregnant women, patients with contrast agent allergies, or those with renal insufficiency. To achieve radiation-free and contrast-free interventional closure procedures, researchers have developed ultrasound-guided percutaneous interventional techniques, yielding satisfactory treatment outcomes. In some cases, these techniques have even enabled cardiovascular procedures to be performed on an outpatient basis, significantly reducing hospitalization time and costs. This project proposes a large-sample, multicenter, prospective randomized controlled study to determine whether ultrasound-guided percutaneous intervention for ASD with the assistance of specialized instruments is non-inferior to traditional fluoroscopy-guided procedures, while also offering shorter hospital stays and lower medical expenses.In addition, patients with radiation contraindications or who refuse radiation therapy, and who are willing to undergo ultrasound-guided percutaneous atrial septal defect (ASD) closure with the assistance of dedicated devices, will be enrolled in a separate observational cohort (observational cohort study).
Trial Details
NCT Number NCT07054541
Lead Sponsor Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions
(from sponsor)
Atrial Septal Defect (ASD)
Related terms Heart Septal Defects, Atrial
Enrollment 666 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov