Clinical Research Directory

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

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).

Lifetech AcuMark™ Sizing Balloon Post-Market Clinical Follow-up Study

The objective of this PMCF study is to: * confirm the safety and performance of the AcuMarkTM Sizing Balloon * identify previously unknown side-effects * monitor the identified side-effects (related to the procedure or to the medical devices)

Effect of Dexmedetomidine Supplementation to General Anaesthesia in Paediatric Transcatheter Closure of Atrial Septal Defect

The aim of this randomized trial is to determine efficacy of dexmedetomidine in improving quality of recovery in pediatric patients undergoing interventional catheter closure of ASD while maintaining the hemodynamic parameters. Additionally he stress reducing effects of dexmedetomidine will be investigated in this population . The main questions it aims to answer are: Does Dexmedetomidine maintain stable hemodynamics in pediatric patients undergoing transcatheter ASD Closure while improving their quality of recovery? Does dexmedetomidine prolong duration of recovery and time to extubation in pediatric patients ? Does dexmedetomidine exert stress reducing properties in this population? Participants will: Either be administered Dexmedetomidine in a loading/maintenance regimen or a placebo, with hemodynamics being monitored at the baseline, intraoperatively and postoperatively, with recovery time and quality of recovery especially emergence delirium being monitored. Stress hormone levels will be sampled at baseline and postoperatively.