← Back to Clinical Trials
Recruiting NCT06605794

FreeFlow Percutaneous Atrial Septal Shunt for IPAH

Trial Parameters

Condition Pulmonary Arterial Hypertension
Sponsor Shanghai Zhongshan Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2023-09-11
Completion 2027-09-11
Interventions
FreeFlow percutaneous atrial septal shunt

Brief Summary

The goal of this clinical trial is to explore the safety and efficacy of the FreeFlow percutaneous atrial septal shunt for treatment of idiopathic pulmonary arterial hypertension. The main questions it aims to answer are: * Is the FreeFlow percutaneous atrial septal shunt safe to use in patients with idiopathic pulmonary arterial hypertension? * Does the FreeFlow percutaneous atrial septal shunt reduce all-cause mortality and readmission in patients with idiopathic pulmonary arterial hypertension, and how effective is it? Thirty subjects who met the inclusion and exclusion criteria were selected for selective implantation of FreeFlow percutaneous atrial septal shunts after balloon atrial septostomy. Participants will: * underwent balloon atrial septostomy and FreeFlow percutaneous atrial septal shunt implantation. * will be followed up at 24 hours after shunt implantation or before discharge, 1 month, 3 months, 6 months and 12 months.

Eligibility Criteria

Inclusion Criteria: * 18≤ age ≤70 years old, female or male; * 10 mmHg≤ mean right atrial pressure (mRAP) ≤20 mmHg; * The subjects had severe idiopathic pulmonary hypertension (mean pulmonary arterial pressure \> 45 mmHg); * WHO grade III or IV; * NT-proBNP≥650 ng/L; * The subjects were informed of the nature of the study and agreed to all the requirements for participating in the study. They signed the informed consent form and agreed to complete the follow-up and the examinations required for the follow-up. Exclusion Criteria: * Local or systemic sepsis or other acute infection; * Severe coagulopathy; * Allergy to nickel and/or titanium and/or nickel/titanium-based materials; * Patients with contraindications to antiplatelet, coagulant or thrombotic therapy; * Intolerance to contrast media; * Have participated in other drug or device clinical trials during the same period; * Glomerular filtration rate (GFR) \< 50 mL/min; * Patients with severe liver dysfunction (alanine aminotransfer

Related Trials